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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...

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More from Regulation

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Finds No ‘Serious Discrepancies’

 
• By Dean Rudge

The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.

‘Disappointed’ Lipella Seeks Alternatives Following Nasdaq Delisting

 
• By Dean Rudge

Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
• By Dean Rudge

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

More from Policy & Regulation

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
• By Dean Rudge

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

AAM Celebrates Court Backing Over Minnesota Pricing Law

 
• By Dave Wallace

The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.

Medicines For Europe Sets Out Trade Priorities

 
• By Dave Wallace

As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.