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Whistleblowers › Disclosure Requirements › Pharmaceutical Industry

Morgan Lewis - As Prescribed

FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

Morgan Lewis - As Prescribed on

The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more

Robins Kaplan LLP

Your Daily Dose of Financial News

Robins Kaplan LLP on

Soooooo . . . about that whole Brexit thing. A UK High Court has ruled that Britain’s EU withdrawal cannot move forward without the approval of Parliament, setting off more uncertainty and what’s expected to be a series of...more

Mintz - Health Care Viewpoints

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

Mintz - Health Care Viewpoints on

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to...more

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