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September 8, 2022

Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products

Submit Comments by 11/08/2022 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
September 8, 2022

Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products

Submit Comments by 11/08/2022 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
September 7, 2022

CDER and CBER accept first submission to ISTAND Pilot Program

[9/7/2022] FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have accepted the agency’s first submission into the Innovative […]
September 7, 2022

Fluorouracil and Pet Safety

Image CaptionCourtesy Photo For many households, pets are our best friends. For some people they are also indispensable service animals. Many show their affection by licking […]
September 7, 2022

General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products

Submit Comments by 12/07/2022 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
September 7, 2022

Pulmonary-Allergy Drugs Advisory Committee Roster

Janet S. Lee, MD, ATSFExpertise: Pulmonary and Critical Care MedicineTerm: 6/15/2022 – 5/31/2026Professor of MedicineDirector, Acute Lung Injury Center of ExcellenceUniversity of Pittsburgh Medical Center Chair […]
September 6, 2022

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Summary Company Announcement Date: July 28, 2018 FDA Publish Date: March 23, 2020 Product Type: Drugs Generic Drugs Reason for Announcement: Recall Reason Description Due to […]
September 6, 2022

Leaf of Life LLC – 619191 – 08/04/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Michael Alexander Bolin Recipient Title CEO Leaf of Life LLC 4419 S. Kingshighway Blvd.St. Louis, MO 63109United […]
September 2, 2022

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer

On September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients with locally […]
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