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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Provention faces delay in FDA review of diabetes prevention antibody

pharmaphorum

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The study was a key element of the FDA filing, and the first ever evidence that a drug therapy could delay the onset of T1D.

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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

IDStewardship

BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read. Authored by: Timothy P. Gauthier, Pharm.D.,

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Sanofi extends its Pompe range with first Nexviazyme OK

pharmaphorum

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. In 2010, Lumizyme’s label was expanded to the under-right group as well.

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Can you take Tylenol and Motrin together?

The Checkup by Singlecare

RELATED: Ibuprofen savings | Acetaminophen savings Multiple studies, including a 2010 study focused on pain treatment after oral surgery, found the alternating ibuprofen and acetaminophen to be successful. Follow the proper label instructions for each. Canadian Family Physician (2012) Maxigesic Rapid® tablets gain US FDA approval.

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Does gabapentin help you sleep?

The Checkup by Singlecare

Gabapentin is a prescription medication that is FDA-approved to treat epilepsy and neuropathic pain caused by shingles. Healthcare providers often prescribe it for other off-label uses as well, including anxiety , bipolar disorder , and fibromyalgia. Gabapentin is used off-label for many conditions, including sleep.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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