FDA “Broad Agency Announcement” To Fund Generic, Clinical Design Research
Executive Summary
Agency expects to provide $200,000 to $50 million on a wide range of research proposals to support regulatory science and innovation.
You may also be interested in...
Drug Shortage Prevention Could Be Funded Through GDUFA
GPhA recommends FDA deploy user fee research money to look at shortage risk assessment and mitigation strategies, while the trade group continues to look for a product to fit its own shortage prediction model.
Hamburg Trumpets Potential Rewards Of Quality Improvement For Generic Industry
FDA Commissioner takes a softer tone in repeating the message that quality must improve in the generics industry, saying the reward may manifest in inspection policy.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.