Enforcement Updates in Brief

FDA import alerts hit Chinese firms and Teva; EU GMP suspensions hit Bend Research and several Indian firms.

Eight of nine FDA drug GMP import alerts and both inspection refusal import alerts in March through May went to Chinese firms.

The one exception was a drug GMP alert that went to a Teva facility in Hungary.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

US FDA Commissioner Makary Is Learning To Appreciate His Staff

 

After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.

Advocates Want New Bipartisan PBM Reform Package To Stand Alone

 
• By 

A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.

More from North America

Business Background Of New CDER Director George Tidmarsh

 

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By 

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."