In a new draft guidance, the FDA describes which abbreviated approval pathways are available for ANDAs and 505(b)(2) applications. Source: Drug Industry Daily

Developers of antiviral drugs for prophylaxis and treatment of respiratory syncytial virus should expose at least 100 adults in clinical trials ahead of pediatric studies, the FDA said in new…

Rigorous patient preference information should be part of the FDA’s process to determine risks and benefits of new products, Commissioner Scott Gottlieb said in a statement coinciding with the inaugural…

An FDA advisory committee unanimously endorsed Spark Therapeutics’ gene therapy for vision loss. Source: Drug Industry Daily

Boehringer Ingelheim suggested the FDA draft guidance on child resistant packaging labeling, published in August, could confuse consumers who may not understand why only some drug products bear the CRP…

The FDA has formalized its guidelines for sponsors seeking reconsideration of scientific or regulatory issues early in the approval process for generic drugs, issuing a guidance that also affirms the…

The FDA has revised its draft guidance on content and formatting for Risk Evaluation and Mitigation Strategy documents to highlight who is responsible for each required action, rather than just…

Healthcare providers strongly endorsed the 340B program that supplies them with drugs at discount, telling members of a House committee that it’s essential for supporting outreach to underserved communities. Source:…

A Wyoming manufacturer of dietary supplements claimed drug-like qualities for its products without obtaining the drug-marketing approvals that such claims require, the FDA said in a warning letter. Source: Drug…

A libertarian advocacy group that backs right-to-try laws pressed the FDA in federal court to release information about the agency’s “incredibly expeditious” decision to authorize the treatment of two Ebola…