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Product Reviews & Approvals

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Approvals

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Latest From Approvals

Abuse-Deterrent Opioids: US FDA Follows The ‘Route Of Abuse’ To Exclusivity

Inspirion’s MorphaBond win suggests agency’s thinking on three-year exclusivity for abuse-deterrent formulations has ‘evolved’ from a formulation-specific approach to one based on route of abuse.

Policy Approvals

Keeping Track: US FDA Files Another Pfizer Cancer Biologic And TMC's New Antibiotic

The latest drug development news and highlights from our FDA Performance Tracker.

Performance Tracker Approvals

FDA's NDA And BLA Approvals: Ganciclovir

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

FDA's ANDA Approvals

US generic drug approvals and tentative approvals for mid-February.

Approvals Regulation

Pfizer Warning Letter Trips Up Sandoz/Momenta’s Expected Glatopa Launch

Sandoz/Momenta’s generic of Teva’s 40 mg Copaxone appeared imminent – until apparently unrelated FDA warning letter regarding contract manufacturer Pfizer’s McPherson, Kan., plant put review on hold.

Manufacturing Quality

On Tap: Novel Agents Awaiting US FDA Action In 2017

New molecular entities and novel biologics on US FDA's user fee calendar for 2017.

Approvals Regulation
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Drug Reviews

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Latest From Drug Review

Mexico's COFEPRIS: A Friend Or Foe To Industry?

'We have a lot of red tape, but we have a clear red tape,' attorney José Alberto Campos-Vargas says in an interview.

Drug Review Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees

EU Decentralized Procedure Pilot Seeks To Speed Up Validations

All marketing approval applications submitted via Europe’s decentralized procedure are being processed under a new pilot that should help regulators validate applications faster. The pilot might also give companies a better understanding of the validation process and how omissions or mistakes in their documentation might invalidate or delay their applications.

Review Pathway Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees

US FDA Likely Not 'Significant', Could Be Mostly Spared From Trump's Regulation-Slashing Order

But even though executive order that requires regulatory off sets may only have limited application to FDA, limited, experts warn that it still could prove extremely unwieldly to implement.

FDA Drug Review
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