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TXT Pfizer Recalls 5 Accupril Lots [2606 Words] [ Price : $8.95]
FDA says Pfizer is recalling five lots of Accupril due to the presence of a nitrosamine above the acceptable daily level.
04/27/2022
 
 
TXT FDA Pushes Congress for Catalyst Decision Fix [576 Words] [ Price : $8.95]
FDA says it is interested in working with Congress to find a legislative solution, most likely a bill that would be added to the user fee reauthorization package that is moving through Congress, to help overturn a 2021 appeals court decision (Catalyst Pharmaceuticals v. Becerra) that has disrupted FDA’s orphan drug program.
04/27/2022
 
 
TXT Info Collection Revision on Expanded Access Form [117 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection revision entitled “Expanded Access to Investigational Drugs for Treatment Use.”
04/27/2022
 
 
TXT Janssen Sues to Block Counterfeit HIV Meds [2732 Words] [ Price : $8.95]
Janssen asks a New York federal court to stop several drug wholesalers from selling counterfeit versions of the company’s HIV drugs.
04/27/2022
 
 
TXT Postmarketing Safety Electronic Submission Guidance [2664 Words] [ Price : $8.95]
FDA publishes a guidance with general information on the electronic submission of specified postmarketing safety reports to CBER and CDER.
04/27/2022
 
 
TXT Medtronic EMG Tube Airway Risk Evaluated [2694 Words] [ Price : $8.95]
FDA says it is evaluating reports of an increased risk of airway obstruction associated with two Medtronic silicone-based EMG endotracheal tubes.
04/27/2022
 
 
TXT FDA Seeks Industry Rep for Pediatric Panel [63 Words] [ Price : $8.95]
Federal Register notice: FDA seeks industry organizations interested in participating in selecting a nonvoting industry representative to serve on the agency’s Pediatric Advisory Committee.
04/27/2022
 
 
TXT Patel’s Goal as Chief Digital Health Officer [2738 Words] [ Price : $8.95]
CDRH chief digital health officer of global strategy and innovation Bakul Patel explains the work he will be addressing in his new position.
04/27/2022
 
 
TXT Multiple Clinical Resolution Laboratory Violations [2917 Words] [ Price : $8.95]
FDA warns Brea, CA-based Clinical Resources Laboratory about CGMP violations in its production of misbranded unapproved new drugs.
04/26/2022
 
 
TXT No Major Changes in ‘Intended Use’ Reg: Attorney [2753 Words] [ Price : $8.95]
Attorney Bryan Feldhaus says the revised FDA intended use regulation clarifies but does not change the definition of intended use and should not adversely affect off-label communications.
04/26/2022
 
 
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