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Evidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public Health

FDA Law Blog: Biosimilars

In the meantime, this belief was followed for centuries by doctors, to the detriment of countless patients. Galen’s belief in the four humors was sincere and deeply held, and also deeply wrong, as evidence-based science eventually showed.

FDA
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Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

Joint Education Sessions Organize joint education sessions where doctors and pharmacists can provide comprehensive information about generic drugs to patients. Referral System Establish a referral system where doctors can direct patients to pharmacists for more detailed information about generic alternatives. ” FDA.gov, 2021.

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Prescribing Red Flags: Pharmacists Be Wary of What the Doctor Orders

FDA Law Blog: Biosimilars

By Larry K. Houck Last month the U.S.

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Drug Channels News Roundup, November 2020: Rebate Rule Redux, MFN (maybe), Amazon’s Pharmacy Customers, Drug Spending, GPO M&A, and RxTrace

Drug Channels

My recent tweets have highlighted: doctors against step therapy, distribution of COVID-19 therapies, biosimilar savings, copay accumulator data, prospects for smaller PBMs, the new transparency rule, specialty pharmacy profit metrics, the future of oncology practices, and an update on Diplomat founder Phil Hagerman.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

Controlled Substances Received from Multiple Providers Individuals presenting controlled substance prescriptions from multiple prescribers may indicate “doctor shopping.” Complaint ¶ 62. Providers should be aware of the other drugs prescribed to their patients. Complaint ¶ 63.

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The OIG Don’t Like That: Rockin’ The Casbah, Rockin’ the Casbah

FDA Law Blog: Biosimilars

A thought exercise: A company, at the behest of a key opinion leader, donates product to the doctor which the doctor takes overseas to treat sleeping sickness in Africa. Tannoury violated the False Claims Act, that the government could use the same theory for other, benign arrangements. Walk with me a minute.

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Senior FDA Official Dr. Julie Beitz Joins Hyman, Phelps & McNamara, P.C. as Principal Drug Regulatory Expert

FDA Law Blog: Biosimilars

Dr. Beitz earned a Bachelor of Arts (summa cum laude and honors in chemistry) from Barnard College, Columbia University, and a Doctor of Medicine from the College of Physicians and Surgeons, Columbia University.

FDA