4.5 million people at the crossroads of the Americas ; the Gorgas Memorial Institute's century-long tropical disease and vaccine research legacy, a US-dollar economy eliminating currency risk, a Johns Hopkins-affiliated hospital, and Central America's most internationally connected clinical research infrastructure.
Panama's research proposition is built on institutional prestige, operational simplicity, and strategic geography: the Gorgas Memorial Institute's nearly century-long tropical disease and vaccine research platform gives Panama infectious disease research credibility far beyond its 4.5 million population; the US dollar economy eliminates currency risk entirely ; the only Latin American research market where this is true; and Panama City's Tocumen hub-level air connectivity makes it the easiest research market to visit, monitor, and supply in the entire hemisphere.
DNFD/MINSA regulatory framework under Decree 178/2001 incorporating WHO GCP and ICH GCP E6(R2) standards; CONAIS national ethics coordination and multi-site trial approval; institutional CEI ethics committees with established pharmaceutical company relationships at major Panama City research hospitals; MINSA's active PAHO technical assistance partnership continuously improving regulatory capacity; improving DNFD review timelines benefiting from Panama City's multinational pharmaceutical industry presence and regulatory engagement.
The US Dollar is Panama's de facto currency (pegged 1:1 since 1904) ; the only Latin American clinical research market with zero foreign exchange risk for US and international sponsors; no ARS crisis management, no BRL devaluation exposure, no currency hedging required; trial budgets set in USD are what they are; Panama City's sophisticated banking and financial infrastructure handles sponsor payments with US financial system-equivalent simplicity; EST-compatible time zone (UTC-5) aligns Panama City operations directly with US pharmaceutical industry working hours.
4.5M with remarkable ethnic diversity (mestizo, West Indian Afro-Caribbean, Ngäbe-Buglé indigenous, Guna, Chinese-Panamanian) across one regulatory framework; hyperendemic dengue for vaccine and antiviral trials; malaria (vivax and falciparum) in rural and Darién provinces; leishmaniasis and Chagas in forested regions; active hantavirus and arbovirus research populations; Kuna cardiovascular study populations; growing urban Panama City NCD (cardiovascular, diabetes, obesity) patient pools; CSS and MINSA combined coverage providing structured patient access to over 80% of the population.
Gorgas Institute (WHO reference lab; PAHO partner; vaccine trial capacity); Hospital Punta Pacífica (Johns Hopkins Medicine International affiliation; JCI-accredited ; the only Johns Hopkins-affiliated hospital in Central America); Complejo Hospitalario Metropolitano (CSS flagship); Instituto Oncológico Nacional; INDICASAT AIP biomedical research (Ciudad del Saber); Smithsonian Tropical Research Institute scientific community; Tocumen International Airport (Hub of the Americas) with direct flights to US, Europe, and Latin American pharmaceutical hubs; multinational pharmaceutical regional headquarters in Panama City.
Panama City dominates national trial activity through its concentration of MINSA public hospitals, the CSS Complejo Hospitalario Metropolitano, the Gorgas Institute, the Johns Hopkins-affiliated Hospital Punta Pacífica, and the Instituto Oncológico Nacional ; a metropolitan cluster that contains, within a 30-minute drive of Tocumen Airport, the full spectrum of research infrastructure from WHO-reference tropical disease laboratories to JCI-accredited international private medicine. The interior provinces extend Panama's geographic research reach into the endemic tropical disease and indigenous population corridors of Veraguas, Chiriquí, and Bocas del Toro.
| # | Site | City | Notes |
|---|---|---|---|
| 01 | Instituto Conmemorativo Gorgas de Estudios de la Salud | Panama City | Panama's most globally prestigious research institution ; a WHO reference laboratory and PAHO partner founded in 1928 by the US Congress to study tropical diseases on the Panamanian isthmus and named after Colonel William Crawford Gorgas, whose anti-yellow fever and anti-malaria campaigns enabled Panama Canal construction; Phase I–III activity across dengue (vaccine and antiviral trials with multiple manufacturers), malaria, Chagas disease, leishmaniasis, hantavirus, Zika, Ebola vaccine (rVSV-ZEBOV Phase III), COVID-19, and emerging arboviral pathogens; maintains active partnerships with NIH, CDC, WRAIR, LSHTM, and the Smithsonian Tropical Research Institute; the Americas' most internationally credentialed dedicated tropical disease research institution still operating at its founding location, providing sponsors with nearly a century of institutional research continuity in a tropical disease environment of unparalleled ecological richness. |
| 02 | Hospital Punta Pacífica | Panama City | Panama's most internationally accredited private hospital ; affiliated with Johns Hopkins Medicine International, making it the only Johns Hopkins-affiliated hospital in Central America ; and the country's most sophisticated Phase II–IV commercial research institution; JCI-accredited; active trial portfolio across oncology, cardiovascular, metabolic disease, and internal medicine; Hospital Punta Pacífica's Johns Hopkins affiliation creates a research culture, documentation standard, and pharmaceutical company relationship quality comparable to Johns Hopkins-connected academic centres in the United States; its Pacific coast Panama City location provides direct access to Panama City's upper-income professional and expatriate population ; a demographically international patient catchment whose English proficiency, health literacy, and trial compliance rates reflect the Canal Zone's legacy of multinational community engagement. |
| 03 | Complejo Hospitalario Metropolitano (Caja de Seguro Social) | Panama City | Panama's largest hospital ; the flagship of the Caja de Seguro Social (CSS) health insurance system, covering approximately 75% of formal sector workers and their dependants ; and the most research-active public institution in Panama for Phase II–III commercial trial enrollment; cardiovascular, oncology, haematology, metabolic disease, and internal medicine trial activity; the Complejo Hospitalario Metropolitano's sheer patient volume ; managing tens of thousands of outpatient consultations through a fully integrated insurance-based healthcare system ; creates structured research access to Panama City's large mestizo middle-class patient population; CSS's electronic patient management systems provide feasibility data infrastructure that supports commercial Phase II–III trial site selection and enrollment planning. |
| 04 | Hospital Santo Tomás | Panama City | One of Central America's oldest continuously operating public hospitals ; MINSA's primary general hospital in Panama City, treating approximately 300,000 patients per year ; and a major research site for infectious disease, haematology, oncology, and internal medicine; a key site for Gorgas Institute clinical trial partnerships, as its high-volume infectious disease and tropical medicine wards provide patient populations for Gorgas-initiated Phase II–III programs; Hospital Santo Tomás's patient catchment from Panama City's lower-income and migrant population ; including internal migrants from indigenous communities of Darién, Ngäbe-Buglé, and Bocas del Toro ; creates research access to the tropical disease patient populations most relevant to Panama's endemic infectious disease burden. |
| 05 | Instituto Oncológico Nacional (ION) | Panama City | Panama's national cancer institute ; the country's reference oncology treatment and research centre under MINSA ; with Phase II–IV commercial trial activity across solid tumours (cervical cancer, colorectal cancer, breast cancer, and lung cancer) and haematological malignancies; ION coordinates Panama's national oncology trial network and provides the epidemiological cancer registry data underlying commercial oncology trial feasibility assessments; while Panama's absolute patient volumes are smaller than larger LATAM markets, ION's concentrated national oncology catchment and its active international cooperative group connections provide Phase II–III oncology enrollment through a structured national programme that gives sponsors access to Panama's full cancer patient population through a single institutional partner. |
| 06 | Hospital del Niño Dr. José Renán Esquivel | Panama City | Panama's national paediatric hospital ; the country's reference centre for childhood infectious disease, haematology, and paediatric medicine ; and a key site for paediatric Phase II–III clinical trials in infectious disease indications including dengue vaccine immunogenicity studies in children, malaria chemoprevention, respiratory virus programs, and paediatric antibiotic trials; the Hospital del Niño's location adjacent to the Gorgas Institute creates a natural clinical partnership for vaccine studies requiring paediatric immunogenicity data in a dengue and malaria-endemic population; an essential site for sponsors whose programs require paediatric safety and efficacy data in tropical disease-endemic environments unavailable in non-tropical, high-income research markets. |
| 07 | Clínica Hospital San Fernando | Panama City | One of Panama City's most established private research hospitals ; a comprehensive private medical centre with decades of commercial pharmaceutical company relationship management ; and an active Phase II–IV trial site across oncology, cardiovascular, metabolic disease, and internal medicine; Clínica San Fernando's patient catchment from Panama City's middle-to-upper-income residential districts provides research access to the professional and business class demographic whose stable health insurance, high treatment compliance, and English proficiency create trial participation patterns comparable to private hospital research populations in Southern Europe or high-income Latin American markets such as Buenos Aires or Santiago. |
| 08 | Hospital Nacional | Panama City | A major private hospital in central Panama City and an active Phase II–III commercial research site across oncology, cardiovascular, and internal medicine indications; Hospital Nacional's central Panama City location ; adjacent to the Via España commercial corridor ; provides research access to the dense urban patient catchment of central Panama City across the full spectrum of commercial insurance and private pay demographics; its established pharmaceutical company relationships and experienced clinical research coordination team have sustained an active commercial trial portfolio complementary to the larger CSS and MINSA public hospital research networks; an important private hospital complement for sponsors designing Panama City multi-site Phase III designs requiring patient coverage beyond the public and Johns Hopkins-affiliated private hospital network. |
| 09 | INDICASAT AIP ; Instituto de Investigaciones Científicas y Servicios de Alta Tecnología | Panama City | Panama's national biomedical and advanced technology research institute ; located within the Ciudad del Saber (City of Knowledge) science and innovation campus built on the former US military base of Fort Clayton, adjacent to the Panama Canal ; conducting genomics, natural products drug discovery, and translational biomedical research with active connections to the Gorgas Institute, the Smithsonian Tropical Research Institute, and international pharmaceutical and biotech partners; INDICASAT AIP's biomedical research programmes ; including pharmacogenomics of Panamanian indigenous populations, tropical disease pathogen genomics, and natural product drug discovery from Panama's extraordinary biodiversity ; provide the translational science substrate that connects Gorgas Institute's clinical research to the drug discovery pipeline most relevant to Panama's unique pathogen and population ecosystem; the Ciudad del Saber campus's international organization community creates a continuously rotating scientific presence that supports Panama's claim to research infrastructure of global scientific breadth. |
| 10 | Hospital Nicolás A. Solano | La Chorrera | A major CSS regional hospital in La Chorrera ; the western Panama metropolitan area's most populous municipality, approximately 35 km west of Panama City, with a population of approximately 200,000 ; and an active Phase II–III research site for cardiovascular, metabolic disease, and infectious disease indications; Hospital Solano's CSS managed care patient base provides structured patient access to the western Panama metropolitan corridor whose demographics and disease burden ; reflecting a rapidly urbanising mestizo population transitioning from rural to suburban lifestyle ; make it representative of the NCD and metabolic disease burden that is the most commercially significant growing research area in Panama's clinical trial market; an important geographic extension of Panama City's research network for sponsors requiring greater metropolitan patient distribution. |
| 11 | Hospital Luis "Chicho" Fábrega | Santiago | The primary reference hospital for Veraguas Province in the Panamanian interior ; the province occupying Panama's narrow central waist with both Caribbean and Pacific coastlines ; and an important Phase II–III research site for infectious disease and general medicine; its position in the Panamanian interior provides research access to patient populations whose rural tropical disease exposure profiles ; including malaria, Chagas, and cutaneous leishmaniasis ; are distinct from the urban Panama City patient catchment, and whose predominantly mestizo and indigenous demographic reflects Panama's interior agricultural population; Hospital Fábrega has participated in national infectious disease research programs coordinated through the Gorgas Institute and serves as the primary hospital for Veraguas Province's approximately 250,000 residents. |
| 12 | Hospital José Domingo de Obaldía | David | Western Panama's major reference hospital ; located in David, the capital of Chiriquí Province (~150,000 people) and the commercial centre of Panama's western agricultural region ; and the primary research institution for western Panama's population including the Ngäbe-Buglé indigenous comarca territories; Phase II–III activity across infectious disease, cardiovascular, and internal medicine; Hospital Obaldía's proximity to the Ngäbe-Buglé indigenous community ; Panama's largest indigenous group, residing primarily in the Ngäbe-Buglé comarca straddling Chiriquí, Bocas del Toro, and Veraguas provinces ; creates research access to an indigenous population whose genetic profile (distinct from Guna, Kuna, Emberá, and Andean indigenous groups) is of pharmacogenomic interest for sponsors studying Amerindian drug metabolism in Central American indigenous populations; the western Panama corridor's malaria and tropical disease burden adds infectious disease research relevance to this regional hospital's catchment. |
Panama's most globally prestigious research institution ; a WHO reference laboratory and PAHO partner founded in 1928 by the US Congress to study tropical diseases on the Panamanian isthmus and named after Colonel William Crawford Gorgas, whose anti-yellow fever and anti-malaria campaigns enabled Panama Canal construction; Phase I–III activity across dengue (vaccine and antiviral trials with multiple manufacturers), malaria, Chagas disease, leishmaniasis, hantavirus, Zika, Ebola vaccine (rVSV-ZEBOV Phase III), COVID-19, and emerging arboviral pathogens; maintains active partnerships with NIH, CDC, WRAIR, LSHTM, and the Smithsonian Tropical Research Institute; the Americas' most internationally credentialed dedicated tropical disease research institution still operating at its founding location, providing sponsors with nearly a century of institutional research continuity in a tropical disease environment of unparalleled ecological richness.
Panama's most internationally accredited private hospital ; affiliated with Johns Hopkins Medicine International, making it the only Johns Hopkins-affiliated hospital in Central America ; and the country's most sophisticated Phase II–IV commercial research institution; JCI-accredited; active trial portfolio across oncology, cardiovascular, metabolic disease, and internal medicine; Hospital Punta Pacífica's Johns Hopkins affiliation creates a research culture, documentation standard, and pharmaceutical company relationship quality comparable to Johns Hopkins-connected academic centres in the United States; its Pacific coast Panama City location provides direct access to Panama City's upper-income professional and expatriate population ; a demographically international patient catchment whose English proficiency, health literacy, and trial compliance rates reflect the Canal Zone's legacy of multinational community engagement.
Panama's largest hospital ; the flagship of the Caja de Seguro Social (CSS) health insurance system, covering approximately 75% of formal sector workers and their dependants ; and the most research-active public institution in Panama for Phase II–III commercial trial enrollment; cardiovascular, oncology, haematology, metabolic disease, and internal medicine trial activity; the Complejo Hospitalario Metropolitano's sheer patient volume ; managing tens of thousands of outpatient consultations through a fully integrated insurance-based healthcare system ; creates structured research access to Panama City's large mestizo middle-class patient population; CSS's electronic patient management systems provide feasibility data infrastructure that supports commercial Phase II–III trial site selection and enrollment planning.
One of Central America's oldest continuously operating public hospitals ; MINSA's primary general hospital in Panama City, treating approximately 300,000 patients per year ; and a major research site for infectious disease, haematology, oncology, and internal medicine; a key site for Gorgas Institute clinical trial partnerships, as its high-volume infectious disease and tropical medicine wards provide patient populations for Gorgas-initiated Phase II–III programs; Hospital Santo Tomás's patient catchment from Panama City's lower-income and migrant population ; including internal migrants from indigenous communities of Darién, Ngäbe-Buglé, and Bocas del Toro ; creates research access to the tropical disease patient populations most relevant to Panama's endemic infectious disease burden.
Panama's national cancer institute ; the country's reference oncology treatment and research centre under MINSA ; with Phase II–IV commercial trial activity across solid tumours (cervical cancer, colorectal cancer, breast cancer, and lung cancer) and haematological malignancies; ION coordinates Panama's national oncology trial network and provides the epidemiological cancer registry data underlying commercial oncology trial feasibility assessments; while Panama's absolute patient volumes are smaller than larger LATAM markets, ION's concentrated national oncology catchment and its active international cooperative group connections provide Phase II–III oncology enrollment through a structured national programme that gives sponsors access to Panama's full cancer patient population through a single institutional partner.
Panama's national paediatric hospital ; the country's reference centre for childhood infectious disease, haematology, and paediatric medicine ; and a key site for paediatric Phase II–III clinical trials in infectious disease indications including dengue vaccine immunogenicity studies in children, malaria chemoprevention, respiratory virus programs, and paediatric antibiotic trials; the Hospital del Niño's location adjacent to the Gorgas Institute creates a natural clinical partnership for vaccine studies requiring paediatric immunogenicity data in a dengue and malaria-endemic population; an essential site for sponsors whose programs require paediatric safety and efficacy data in tropical disease-endemic environments unavailable in non-tropical, high-income research markets.
One of Panama City's most established private research hospitals ; a comprehensive private medical centre with decades of commercial pharmaceutical company relationship management ; and an active Phase II–IV trial site across oncology, cardiovascular, metabolic disease, and internal medicine; Clínica San Fernando's patient catchment from Panama City's middle-to-upper-income residential districts provides research access to the professional and business class demographic whose stable health insurance, high treatment compliance, and English proficiency create trial participation patterns comparable to private hospital research populations in Southern Europe or high-income Latin American markets such as Buenos Aires or Santiago.
A major private hospital in central Panama City and an active Phase II–III commercial research site across oncology, cardiovascular, and internal medicine indications; Hospital Nacional's central Panama City location ; adjacent to the Via España commercial corridor ; provides research access to the dense urban patient catchment of central Panama City across the full spectrum of commercial insurance and private pay demographics; its established pharmaceutical company relationships and experienced clinical research coordination team have sustained an active commercial trial portfolio complementary to the larger CSS and MINSA public hospital research networks; an important private hospital complement for sponsors designing Panama City multi-site Phase III designs requiring patient coverage beyond the public and Johns Hopkins-affiliated private hospital network.
Panama's national biomedical and advanced technology research institute ; located within the Ciudad del Saber (City of Knowledge) science and innovation campus built on the former US military base of Fort Clayton, adjacent to the Panama Canal ; conducting genomics, natural products drug discovery, and translational biomedical research with active connections to the Gorgas Institute, the Smithsonian Tropical Research Institute, and international pharmaceutical and biotech partners; INDICASAT AIP's biomedical research programmes ; including pharmacogenomics of Panamanian indigenous populations, tropical disease pathogen genomics, and natural product drug discovery from Panama's extraordinary biodiversity ; provide the translational science substrate that connects Gorgas Institute's clinical research to the drug discovery pipeline most relevant to Panama's unique pathogen and population ecosystem; the Ciudad del Saber campus's international organization community creates a continuously rotating scientific presence that supports Panama's claim to research infrastructure of global scientific breadth.
A major CSS regional hospital in La Chorrera ; the western Panama metropolitan area's most populous municipality, approximately 35 km west of Panama City, with a population of approximately 200,000 ; and an active Phase II–III research site for cardiovascular, metabolic disease, and infectious disease indications; Hospital Solano's CSS managed care patient base provides structured patient access to the western Panama metropolitan corridor whose demographics and disease burden ; reflecting a rapidly urbanising mestizo population transitioning from rural to suburban lifestyle ; make it representative of the NCD and metabolic disease burden that is the most commercially significant growing research area in Panama's clinical trial market; an important geographic extension of Panama City's research network for sponsors requiring greater metropolitan patient distribution.
The primary reference hospital for Veraguas Province in the Panamanian interior ; the province occupying Panama's narrow central waist with both Caribbean and Pacific coastlines ; and an important Phase II–III research site for infectious disease and general medicine; its position in the Panamanian interior provides research access to patient populations whose rural tropical disease exposure profiles ; including malaria, Chagas, and cutaneous leishmaniasis ; are distinct from the urban Panama City patient catchment, and whose predominantly mestizo and indigenous demographic reflects Panama's interior agricultural population; Hospital Fábrega has participated in national infectious disease research programs coordinated through the Gorgas Institute and serves as the primary hospital for Veraguas Province's approximately 250,000 residents.
Western Panama's major reference hospital ; located in David, the capital of Chiriquí Province (~150,000 people) and the commercial centre of Panama's western agricultural region ; and the primary research institution for western Panama's population including the Ngäbe-Buglé indigenous comarca territories; Phase II–III activity across infectious disease, cardiovascular, and internal medicine; Hospital Obaldía's proximity to the Ngäbe-Buglé indigenous community ; Panama's largest indigenous group, residing primarily in the Ngäbe-Buglé comarca straddling Chiriquí, Bocas del Toro, and Veraguas provinces ; creates research access to an indigenous population whose genetic profile (distinct from Guna, Kuna, Emberá, and Andean indigenous groups) is of pharmacogenomic interest for sponsors studying Amerindian drug metabolism in Central American indigenous populations; the western Panama corridor's malaria and tropical disease burden adds infectious disease research relevance to this regional hospital's catchment.
These are the primary regulatory, academic, and industry bodies shaping Panama's clinical research ecosystem.
Panama's pharmaceutical regulatory authority ; the DNFD operating within the Ministerio de Salud (MINSA) ; governing clinical trial authorisation under Decree 178/2001 and subsequent resolutions incorporating WHO GCP and ICH GCP E6(R2) standards; DNFD's clinical trial review process operates in parallel with CONAIS ethics approval; Panama's active PAHO technical assistance partnership and bilateral US FDA health cooperation agreements have supported DNFD's progressive capacity building toward internationally aligned pharmaceutical review standards.
Panama's national health research ethics coordination body under MINSA, responsible for approving multi-site and Phase I–III clinical trial protocols at the national level, accrediting institutional CEIs, and setting national standards for research ethics review in alignment with the Declaration of Helsinki and CIOMS guidelines; CONAIS's parallel review process with DNFD is designed to achieve combined regulatory and ethics approval within a single coordinated timeline.
Panama's national science, technology, and innovation authority ; the government body funding and coordinating Panama's biomedical research through competitive grants, international cooperation agreements, and strategic research priority programmes; SENACYT's biomedical research programmes support the Gorgas Institute, INDICASAT AIP, and university-based health research; its international collaboration frameworks with NIH, European research councils, and LSHTM facilitate the public-private research partnerships through which Panama's tropical disease and vaccine research capacity is sustained.
Panama's premier and most globally recognised research institution ; a WHO reference laboratory and PAHO regional partner operating since 1928 in continuous tropical disease research on the Panamanian isthmus; the Gorgas Institute's Phase I–III vaccine and therapeutic trial portfolio ; spanning Ebola (rVSV-ZEBOV), dengue, malaria, Zika, and COVID-19 in recent years ; demonstrates a breadth of platform trial activation across pathogen classes that very few institutions globally can match.
Panama's national biomedical and advanced technology research institute ; located in the Ciudad del Saber science campus on the former US military base of Fort Clayton adjacent to the Canal ; conducting genomics, pharmacogenomics, natural product drug discovery, and translational biomedical research; INDICASAT AIP's active Gorgas Institute and Smithsonian Tropical Research Institute partnerships position it at the intersection of clinical, ecological, and genomic tropical medicine research.
Panama's primary public university and the institutional source of the national medical investigator pipeline ; affiliated with Hospital Santo Tomás and other MINSA teaching hospitals ; whose Faculty of Medicine produces the physician investigator community that staffs commercial trial activity across Panama's public hospital research network.
One of the world's premier tropical biology research institutions ; headquartered in Panama City and operating field stations throughout Panama's most ecologically significant sites including Barro Colorado Island, Gamboa, Bocas del Toro, and the Azuero Peninsula ; whose permanent scientific community of international researchers creates a continuously rotating presence of world-class biological scientists in Panama.
Global CRO with Panama operations managed through its Latin America Central America regional network ; supporting Phase II–IV programs across infectious disease (dengue, malaria, tropical diseases through Gorgas Institute partnerships), oncology, cardiovascular, and metabolic disease indications; DNFD regulatory submission expertise and CONAIS ethics application support.
International CRO with Panama operations supporting Phase II–IV infectious disease, vaccine, oncology, and cardiovascular programs; specialist tropical disease and vaccine trial management experience with direct Gorgas Institute partnership history; DNFD regulatory strategy and CONAIS ethics navigation support.
Global CRO with Central American operations covering Panama across oncology, cardiovascular, metabolic disease, and infectious disease Phase II–III programs; DNFD submission expertise and CONAIS ethics application support; Central America regional programme coordination supporting sponsors designing Panama-anchored Central American multi-country research networks extending into Costa Rica, Guatemala, and Honduras.
International biopharmaceutical solutions company with Panama and Central American operations providing integrated Phase I–IV clinical development services; infectious disease and vaccine trial management expertise reflecting Panama's Gorgas-anchored research profile; DNFD regulatory affairs and CONAIS ethics committee support.
Keep exploring
Discover 11 early-phase clinical trials and design frameworks redefining development strategy in 2025-2026, and what sponsors can learn to reduce late-stage failure risk.
Four pervasive AI misconceptions in clinical trials that derail programs, inflate costs, and create regulatory exposure, with evidence on what the data actually shows.
Before selecting an AI patient screening tool for clinical trial recruitment, ask these 7 critical questions to avoid costly mismatches and protocol failures.
Accelerated Approval is an FDA pathway that allows earlier approval of drugs treating serious conditions and filling unmet medical need on the basis of a surrogate endpoint that is reasonably likely to predict clinical benefit, conditional on confirmatory post-marketing trials.