Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable

 
• By Bowman Cox
  
Generate a summary of this article
Listen to this article
Beta

Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.

agency urged to take complaints seriously

An investigation by the US Food and Drug Administration that failed to substantiate an agency whistleblower’s allegations of improperly downgraded and limited biologics inspections drew harsh words from the US Office of Special Counsel, the independent federal investigative and prosecutorial agency that protects federal employees from reprisal for whistleblowing.

The agency's report regarding the former FDA Team Biologics investigator’s allegations of lax oversight met statutory requirements, but its findings...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Manufacturing

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

UK MHRA First-Half New Drug Approvals Show Overwhelming Use Of EU Reliance Procedures

 
• By Ian Schofield

The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 
• By Francesca Bruce

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

More from Compliance

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 
• By Francesca Bruce

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

India And Pakistan Boost Transparency In Industry-Doctor Interactions

 
• By Vibha Sharma

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.