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September 16, 2021

FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

On September 15, 2021, the Food and Drug Administration granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals, Inc.) for adult patients with locally advanced or metastatic […]
September 15, 2021

Pediatric Review Committee (PeRC)

PeRC is an internal committee established under the Food and Drug Administration Amendments Act (FDAAA) to carry out activities related to BPCA and PREA. Content current […]
September 14, 2021

5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC

Image Delta-8 tetrahydrocannabinol, also known as delta-8 THC, is a psychoactive substance found in the Cannabis sativa plant, of which marijuana and hemp are two varieties. […]
September 14, 2021

McDaniel Water, LLC – 616186 – 09/07/2021

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Gary McDaniel/Ruth Shields Recipient Title Directors McDaniel Water, LLC 23711 Hix DriveCanyon, TX 79015United States [email protected] Issuing […]
September 14, 2021

Brilliant Enterprises LLC – 609523 – 07/20/2021

Delivery Method: VIA UPS and Electronic Mail Product: DrugsFood & Beverages Recipient: Recipient Name Adam and Angela Schultz Brilliant Enterprises LLC 621 Main Street, Unit 182Gaylord, […]
September 14, 2021

Drug Promotion

[embedded content] FDA reviews advertising and promotional materials for prescription drugs to ensure the content isn’t false or misleading. FDA Drug Info Rounds pharmacists discuss the […]
September 14, 2021

Drug Name Review

[embedded content] Before any drug reaches the market, its name is thoroughly examined to identify misleading or potentially confusing names. FDA Drug Info Rounds pharmacists discuss […]
September 14, 2021

Communicating Benefit and Risk Information

[embedded content] Every medication approved by the FDA has benefits as well as risks. It’s important that patients hear both, and have a clear understanding so […]
September 13, 2021

Transcript: Electronic Orange Book

HOST: Captain Mary Kremzner   PHARMACIST: Lieutenant Lindsay Davison   Captain Kremzner: The Orange Book has long been a reliable resource for information about FDA-approved drugs. […]
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