1. Generics Bulletin
  2. >>Policy & Regulation
  3. >>Regulation

FDA Insists Its Quality Controls Are Up To The Task

 
• By Dave Wallace

Commissioner Scott Gottlieb and center for drug evaluation and research (CDER) director Janet Woodcock have insisted that the FDA is maintaining “strong oversight of generic drug quality issues domestically and abroad”.

Quality
Patients And Consumers Should Feel Confident About The FDA’s Quality Controls, The Agency Says • Source: Shutterstock

Allegations of substandard quality controls are not a new phenomenon for the generics industry. However, it is rare for an industry regulator to produce as comprehensive and pointed a response to such criticism as has just been published by the US Food and Drug Administration (FDA).

In a lengthy statement – apparently positioned as a rebuttal to media coverage suggesting deficiencies in the FDA’s quality oversight...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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
Start Free Trial

Already a subscriber?

More from Regulation

Regulatory Recap: EU Pharma Package Progresses Forward With Extended Data Protection

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

US ‘Red Tape’ Bill Again Targets Biosimilar Interchangeability – Will It Succeed This Time?

 
• By Dave Wallace

After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?

Sandoz Scores Regional First With EU Launch Of Autoinjectable Stelara Rival

 
• By Adam Zamecnik

Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.

More from Policy & Regulation

UK-EU Deal ‘Must Include Medicines, Not Just Sausages,’ Urges Medicines UK

 
• By Urtė Fultinavičiūtė

The UK struck three international agreements in May, but two of them failed to include medicines or provide any benefits for the pharmaceutical sector. Medicines UK warned that protecting medicine supplies should be of the same importance as defense.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?