News

FDA to issue new vaccine approval guidance amid questions over coronavirus shots
FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...
FDA’s Makary: Covid shot guidance coming soon
FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers for annually updating their Covid-19 shots.
FDA chief wary of federal recommendations for Covid-19 vaccines
The Food and Drug Administration commissioner repeatedly said patients should rely on guidance from their doctors.
Green Matters on MSN6d
FDA Updates Consumer Guidance to Most Severe Warning: All About the Deadly Tomato Recall
What was once a cautioned recall due to the possible presence of Salmonella in tomatoes sold in three states is now labeled ...
STAT28d
FDA commissioner says new vaccine ‘framework’ for industry is coming within weeks
WASHINGTON — Food and Drug Administration Commissioner Marty Makary said the agency is planning to unveil new guidance for vaccine ... so they have a predictable FDA where they don’t have ...
As ivermectin goes over the counter, some pharmacists worry about a lack of guidance
The drug, used to treat parasitic worms, has not been formulated or labeled specifically for over-the-counter use, like ...
BioSpace10dOpinion
Opinion: New FDA Guidelines Raise the Bar on Nitrosamine Testing for Pharma Industry
In 2018, the FDA began an investigation into nitrosamine impurities in drugs that led to high-profile recalls for heartburn ...
ENvue Medical Granted U.S. Patent for Pediatric Feeding Tube Guidance System
NanoVibronix, Inc. (NASDAQ: NAOV) ("NanoVibronix" or the "Company"), a medical technology company specializing in therapeutic devices, announced today, through its ENvue Medical Holdings LLC division ...
BioPharma Dive7d
FDA’s AI tool ‘Elsa’ is here, and the industry has questions
The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's ...