Development of Anti Infective Drug Products for the Pediatric Population
Development of Anti Infective Drug Products for the Pediatric Population guidance is to provide general recommendations on the development of anti-infective drug products, including…
Read more →Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) is being guidance provided by the FDA. Nonalcoholic steatohepatitis…
Read more →Principles of Premarket Pathways for Combination Products
Principles of Premarket Pathways for Combination Products amendments include enhancing clarity, predictability, efficiency, and consistency of premarket regulatory expectations for combination products, including by…
Read more →Population Pharmacokinetics
Population Pharmacokinetics guidance is intended to assist sponsors and applicants of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs),…
Read more →Pre Launch Activities Importation Requests (PLAIR)
Pre Launch Activities Importation Requests (PLAIR) guidance finalizes the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR), which describes the FDA’s policy regarding…
Read more →Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry guidance provides recommendations to sponsors of drugs or…
Read more →