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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

The FDA Law Blog

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

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Is the Listing of REMS Patents in the Orange Book Patently Anticompetitive?

The FDA Law Blog

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S.

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Aduhelm approval controversy dials up as FDA seeks probe

pharmaphorum

In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives. In the letter, she writes: “FDA’s decisions are far ranging and it is inevitable that some of those decisions will lead to controversy.”

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Skinny Label and Induced Infringement: The Saga Continues

The FDA Law Blog

government in the now-infamous (at least in FDA circles) Teva v. Other communications may suffice to show infringement, but carved-out labeling more accurately reflects an intent not to encourage infringement, reasons the Government, extensively citing Judge Prost’s Federal Circuit dissent. GSK skinny label case , the U.S.

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6 common patient questions about insulin biosimilars

The Checkup by Singlecare

Yes, as of March 2020 , insulin is considered a biologic product by the FDA. Regulatory bodies such as the FDA conduct thorough tests to confirm that they meet safety, purity, and potency standards. The FDA Purple Book database can be a good resource to determine whether a biologic drug is interchangeable.

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Antidepressants and Suicide: Why Don’t People Think There’s a Link?

The People's Pharmacy

When she died, she had just been put on an antidepressant with a black-box FDA suicide warning. Many years ago, in our book, Graedons’ Best Medicine (1991), we wrote about the evolution of Prozac: “When Prozac (fluoxetine) was introduced in 1987 it barely made a splash. Therapy sessions turned into 15 minute “med checks.”

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Amplifying the patient voice for better engagement, recruitment and retention

pharmaphorum

I wrote an Amazon-bestselling book called ‘Patient Recruitment for Clinical Trials using Facebook Ads’ that provides the foundations for how you can reach patients on Facebook. Prime Global are experts in medical communications, market access, patient insights, engagement, and recruitment. About Prime Global.