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Generic Labeling Rule Defies Predictions, Remains In FDA's Long-Term Pipeline

 
• By Michael Cipriano

Policy that would allow generic sponsors to change product labels has been delayed yet again, not spiked completely, even with Commissioner Gottlieb's known opposition to the rule.

Machinery cogwheels, industry concept

When Scott Gottlieb was tapped by President Trump to be commissioner of the US FDA, it was almost a forgone conclusion that the agency would scrap a proposed rule that would allow abbreviated new drug application (ANDA) sponsors to change their product labels without getting prior approval.

But at least for now, it appears FDA is simply pushing the proposed rule to the backburner.

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More from Regulation

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

UK-India FTA Could Offer ‘Significant Benefits’ For Generics And Biosimilars

 
• By Dave Wallace

A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

More from Policy & Regulation

Cutting Out The Middlemen? Trump’s Pricing Order Offers Opportunity On PBMs

 
• By Dave Wallace

Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Trump Order On Domestic Manufacturing Wins Plaudits From Industry

 
• By Dave Wallace

An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.