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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Providing significant policy support to the annual update of the Orange Book Preface.

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Drug Patent Research: Expert Tips for Using the FDA Orange and Purple Books

Drug Patent Watch

"Unlocking the Secrets of the FDA's Orange and Purple Books: Insider Tips from a Drug Patent Research Expert As the pharmaceutical industry continues to evolve at breakneck speed, staying ahead of the curve requires more than just a keen eye for innovation it demands a deep understanding of the regulatory landscape.

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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

The question is important because the result of that determination could drastically reduce the amount of patent term to be restored.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent.

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Unicorns Don’t Exist: Rethinking the Generalist Model in Oncology Pharmacy

Pharmacy Times

But together, they contribute to the ever-expanding expectation that oncology pharmacists should “know all the things,” an emotion aptly captured by Allie Brosh in her book Hyperbole and a Half. Touchstone Books; 2013. Time Enough for Love. Putnam’s Sons; 1973. Rao KV, Gulbis AM, Mahmoudjafari Z.

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Investigating the Pharmacist’s Role in Psychedelic-Assisted Psychotherapy for Patients With Cancer

Pharmacy Times

In the 2017 book The Big Picture , author Sean Carroll seamlessly blends the scientific with the philosophical and comments that “life is not a substance, like water or rock; it’s a process, like fire or a wave crashing on the shore.

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Resident Mental Health Matters

Pharmacy Times

I took her advice and celebrated by starting a new book and going to a nice dinner with my husband, which was much needed. My preceptor said, “[Because] you finished your fall seminar, your goal this weekend is to take a break for a day and to take some time to celebrate your accomplishment.”