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Possible Orange Book Revisions Back In Play With US FDA Report To Congress

 
• By Brenda Sandburg

Agency is setting up an internal working group to assess whether certain patent information should be included or removed from the Orange Book. PhRMA, AAM and others address therapeutic equivalence ratings and listing of device-related and REMS-related patents.

US FDA is evaluating whether to make improvements to its Orange Book • Source: Alamy

The Orange Book Transparency Act signed into law last year required the US Food and Drug Administration to solicit public comments on what patent information should be included in the Orange Book. The agency had already completed this task, so it reopened the docket for further input and is now evaluating possible revisions to the publication.

Last month, the FDA submitted a report to Congress summarizing the comments it received without specifying who made the...

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More from US FDA

As US FDA Turns: Can Makary, Prasad And Pazdur Make It Work?

 
• By Michael McCaughan

The FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad, and Commissioner Martin Makary get along?

CBER Poised for Research Shakeup As Prasad Makes Unproven Claims About ‘Polluted Science’

 
• By Sarah Karlin-Smith

In an email to staff filled with unsupported accusations about the quality of the center’s research, CBER Director Vinay Prasad said no resources or time should be spent on ongoing projects started before he joined the FDA until discussed with him.

US FDA Cancer Office Keeps Hemorrhaging Staff, Most Land At Industry

 
• By Sarah Karlin-Smith

Merck, Lilly, and Johnson & Johnson are some of the pharma companies who have snagged the many staff leaving the FDA’s oncology positions. The Pink Sheet estimates CDER’s oncology division is operating with about a 20% vacancy rate.

CNPV II: Secondary Indications Feature In Second Batch Of US FDA Voucher Winners

 
• By Ramsey Baghdadi

Five of the six winners of the US FDA’s second batch of Commissioner’s National Priority Vouchers are for secondary indications. That is no accident, Commissioner Makary says.

More from Agency Leadership

EMA’s Combined Scientific Advice Seeks To Boost Approvals For Drugs Tackling Public Health Threats

 
• By Francesca Bruce

A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.

EU Medicines Network Taps Global Specialists To Tackle Capacity Crunch

 
• By Vibha Sharma

EU drug regulators are taking steps to strengthen their assessment capacity by widening access to specialists from outside the EU/EEA.

CNPV II: Secondary Indications Feature In Second Batch Of US FDA Voucher Winners

 
• By Ramsey Baghdadi

Five of the six winners of the US FDA’s second batch of Commissioner’s National Priority Vouchers are for secondary indications. That is no accident, Commissioner Makary says.