Last week, FDA launched Drug Trials Snapshot, a pilot program intended to provide consumers with information about the sex, age, race and ethnicity of clinical participants for six drugs approved in May and June 2014. This pilot is intended to solicit feedback on the content, format and usefulness of the information provided in advance of an expansion of the program to include all new molecular entities subject to an approved NDA beginning in 2015.
The Drug Trials Snapshot website was developed by FDA in response to the requirements in Section 907 of FDASIA that FDA: 1) report to ...
Late last month, the FDA finalized a new guidance document, explaining the agency's current thinking on the circumstances that may arise in connection with an establishment inspection that it would consider to impose an inappropriate limitation on its inspection authority. The Food and Drug Administration Safety and Innovation Act (FDASIA) deems a drug or medical device adulterated if it has been manufactured processed, packed, or held in any factory, warehouse, or establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.
The ...
Blog Editors
Recent Updates
- Exemptions from the Drug Supply Chain Security Act Enhanced Drug Distribution Security Requirements
- Investors, Researchers, and Business Leaders Take Note: $110M Awarded to Advance Women’s Health
- States Fill Gaps in Hospital Workplace Violence Laws—Requiring Law Enforcement Officers, Weapons Detection Screening Policies in Hospitals, and More
- Georgia & North Dakota: More State Judges Question the Constitutionality of Abortion Bans
- OCR Withdraws Appeal of District Court Order Declaring Unlawful and Vacating the “Proscribed Combination” Portion of Its HIPAA Online Tracking Technologies Guidance