News

FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
FDA publishes drug rejection letters for 15 Massachusetts biotechs
In a bid to increase transparency, the U.S. Food and Drug Administration has begun publishing the complete response letters ...
BioPharma Dive5h
FDA, in policy shift, publishes some drug rejection letters
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
US FDA publishes 200 rejection letters in transparency push
The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.
Medscape9h
FDA Issues Early Alert for Medtronic pH Monitoring Capsules
Used for diagnosing gastroesophageal reflux, the devices may not attach or detach correctly, potentially causing serious ...
Potentially deadly mislabeling spurs RITZ recall over allergy risk, FDA says
Here's what to keep an eye out for in your pantry and on grocery store shelves, especially if you're allergic to nuts.
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
Seed Recall Update as FDA Issues Highest Risk Warning
The Whole Herb Company Inc. issued a voluntary recall for select lots of its organic whole celery seeds on May 27 due to potential salmonella contamination.
Enrollment Initiated in Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...
STAT3d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
FDA Issues Highest Risk Warning for Nationwide Chocolate Recall
Weaver Nut Company, Inc. announced a recall for specific lots of its semi-sweet chocolate nonpareils on June 17 due to the undeclared presence of milk.