Tag: FDA

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder Announced by Vanda

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Vanda Pharmaceuticals Inc. announced that on July 19, 2019, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplement...

Ascentage Pharma Given Green Light by FDA to Start Clinical Trials of HQP1351

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Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, announced that the company was...

FDA Initially Rejected AZ’s NDA for Farxiga

The US Food and Drug Administration (FDA) has issued a complete response letter to AstraZeneca regarding the supplemental New Drug Application for Farxiga (dapagliflozin), meaning that the governing b...

Pharma Company Planned to Shred Quality Control Records before FDA Inspection

An Indian pharmaceutical company attempted to dispose of quality-control records a week ahead of a US Food and Drug Administration (FDA) inspection, found FDA officials. Documents were found awaiti...

FDA Accepted Allergan’s NDA for Bimatoprost Sustained-Release

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Allergan, a leading global pharmaceutical company with more than 70 years of heritage in eye care, announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Applic...

FDA Granted Priority Review for Novartis’s Sickle Cell Medicine

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Novartis announced the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) and has granted Priority Review for its investigational sickle cell medicine cri...

EU and US Fully Implemented MRA for Inspections of Manufacturing Sites

With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspection...

Lupin Launches Generic of Novartis’ Gleevec®

Lupin Limited (Lupin) announced the launch of Imatinib Mesylate Tablets, 100 mg (base) and 400mg (base). Lupin's alliance partner Natco had received an approval from the United States Food and Drug Ad...

Lannett in Supply and Distribution Agreement for Levothyroxine Tablets

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Lannett announced it has entered into a future exclusive supply and distribution agreement for the approved Levothyroxine Sodium Tablets USP of Cediprof, a wholly owned subsidiary of privately held Ne...

FDA to Review BLA from Sanofi for Isatuximab

The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for isatuximab from Sanofi for the treatment of patients with relapsed/refractory multiple m...

FDA Warned Three Repackers of API for Violations of CGMP Requirements

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The U.S. Food and Drug Administration has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing business as Eno...

FDA’s Statements on Steps to Make Labeling Information Consistent and Clear

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The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions...

New Candidates on FDA Commissioner Place

Acting FDA Commissioner, Ned Sharpless, is not the only candidate in the running for the permanent role at the US regulatory agency. In a report in the Wall Street Journal, two other contenders are ap...

Scott Gottlieb Joins Pfizer’s Board of Directors

Pfizer Inc. announced the election of Dr. Scott Gottlieb to its Board of Directors, effective immediately. Dr. Gottlieb, age 47, was also appointed to the Regulatory and Compliance Committee and the S...

FDA to Review Sanofi’s MenQuadfi

The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Sanofi’s MenQuadfiTM Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Con...

FDA Warns Patients over Certain Medtronic Insulin Pumps

The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends ...