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 Found Violations of cGMP in Canadian OTC Manufacturer Facility

FDA sent a warning letter, dated May 7, 2019, to Petra Hygienic Systems International, LLC after an inspection of the company’s Concord, Ontario facility found violations of current good manufacturing...

US Court Enters Consent Decree against PharMedium

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U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction between the United States and PharMedium Services, LLC, headquartered in ...

Pharm D Solutions Obliged to Cease the Manufacturing of Drugs Due to Insanitary Conditions

sterile-manufacturing
U.S. District Judge Keith P. Ellison for the Southern District of Texas signed and entered a consent decree of permanent injunction, ordering a Texas-based company and its owners to stop producing com...

J&J Presented Early Results from First-In-Human Study of Monarch™ Platform

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Auris Health, Inc., part of Johnson & Johnson Medical Devices Companies, announced early positive results from an ongoing study designed to evaluate the safety and feasibility of the Monarch Platf...

Boehringer Ingelheim’s SENSCIS® Phase III Trials Met Primary Endpoint

Boehringer Ingelheim announced that the SENSCIS® trial met its primary endpoint: reduction in the annual rate of decline in forced vital capacity (FVC) in patients with systemic sclerosis associated i...

FDA Warns over Risks Using Unapproved Devices for Diabetes Management

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The U.S. Food and Drug Administration is warning patients and health care professionals of risks associated with the use of unapproved or unauthorized devices for diabetes management, including contin...

ImmunoGen Urged by FDA to Run Another Phase III Trial for Mirvetuximab Soravtansine

ImmunoGen, based in Waltham, Mass., announced that the U.S. Food and Drug Administration (FDA) recommended it run a new Phase III clinical trial of mirvetuximab soravtansine in high folate receptor (F...

VENCLEXTA® Received FDA Approval

AbbVie, a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved VENCLEXTA® (venetoclax) in combination with obinutuzumab (GAZYVA®) fo...

FDA Panel Voted on Daiichi’s Cancer Drugs

Daiichi Sankyo’s hope for a regulatory approval of its acute myeloid leukemia therapy quizartinib hit a snag after an advisory panel with the U.S. Food and Drug Administration (FDA) overwhelmingly vot...

FDA Examining Programs for Overseeing Global Operations and International Affairs

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Concerns about the quality and safety of the growing volume of medicines imported to the United States, pressure to set international policies for genome editing of other scientific developments and e...

Manufacturers of Products Labeled as Homeopathic Received FDA Warning Letters

The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) ...

FDA Will Help Promote Competition in the Biologic Market

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FDA is taking a significant action that will help promote competition in the biologic market by providing final guidance on the pathway for “interchangeable” biologics, which may be substituted witho...

FDA Statement On Policies to Understand Effects of Drugs in Pregnant and Nursing Women

It can be a challenge for health care professionals and patients to find quality scientific information about the safety of drugs and biological products when used during pregnancy or breastfeeding. E...

FDA Rejected Second Acacia Pharma NDA

Acacia Pharma has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Barhemsys (amisulpride injection). The letter marks...

New FDA Warning for Insomnia Drugs

The U.S. Food and Drug Administration announced the agency is requiring a new boxed warning – the agency’s most prominent warning – on certain prescription insomnia drugs to better ensure patients and...

FDA to accept GMP inspections from Bulgaria and Cyprus

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In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level e...