Sunday, February 23, 2020

Sunday, February 23, 2020

Latest News

FDA confirms guidance on placebos, blinding for cancer trials

The Food and Drug Administration (FDA) made a recommendation to drugmakers last week stating that they only use placebos in cancer clinical trials in select circumstances.

Sandoz Inc. recalls Losartan Potassium, Ezetimibe

Sandoz Inc. is recalling two medications that treat cholesterol and high blood pressure because the bottles they were packaged in failed to meet child-resistant closure requirements.

FDA Update: July facility inspection results

The U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.

COCONUT COALITION OF THE AMERICAS: The Coconut Coalition of the Americas Launches Initiative to Remove Coconut From the FDA Major Food Allergen List

The Coconut Coalition of the Americas (CCA), announced the launch of an initiative to make it clear that coconuts are not tree nut allergens.

FDA Update: August medical device recalls

Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.

FRESENIUS KABI: Introduces Phenylephrine Hydrochloride Injection, USP

Generic Equivalent to Vazculep® is Newest Addition to Broad Portfolio of Anesthesia and Analgesia Products

FDA plans 17 public meetings in September

Seventeen public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for September, the FDA reported.

FDA Update: June facility inspection results

The U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.

FDA sends enforcement letter to Aclaris Therapeutics over Eskata advertising

The Food and Drug Administration Office of Prescription Drug Promotion recently sent a letter to Aclaris due to false or misleading claims for its direct-to-consumer advertising for Eskata.

FDA Update: July medical device recalls

Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.

CASAA condemns FDA's new anti-vaping ad campaign

President of the Board for The Consumer Advocates for Smoke-free Alternatives Association (CASAA) Bruce Nye compares the Food and Drug Administration’s (FDA) recent $60 million dollar anti-vaping television campaign to “propaganda” and “sloganeering.”

Cannabis advocates urge FDA to ramp up CBD regulation

As the U.S. Food and Drug Administration (FDA) is being flooded with requests to allow CBD in food and supplements, marijuana advocacy groups are eager for federal regulators to monitor the marketplace to help establish some semblance of order.

Curaleaf receives FDA letter about CBD product marketing

The leading vertically integrated multi-state cannabis operator in the U.S. issued a statement last week about a letter it received from the Food and Drug Administration (FDA) addressing the company's CBD product marketing.

Phase 3 CANDLE study slated for Scynexis treatment of VVC

An agreement between pharmaceutical company Scynexis and the U.S. Food and Drug Administration (FDA) was reached under a special protocol assessment (SPA) on the details of the CANDLE (Conditions Affecting Neurocognitive Development and Learning in Early childhood) study for Oral Ibrexafungerp.

FDA plans 6 public meetings in August

Six public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for August, the FDA reported.

FDA Health News