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TXT McKinsey FDA Contract Under Fire at Hearing [599 Words] [ Price : $8.95]
A House Committee on Oversight and Reform hearing sharply criticizes consulting firm McKinsey and Co. for its role in advising Purdue Pharm during the opioid epidemic while also being under contract to advise FDA.
04/27/2022
 
 
TXT Current Merger Enforcement is Working: PhRMA [2837 Words] [ Price : $8.95]
PhRMA cites FDA statistics to support its position that the Federal Trade Commission and Department of Justice don’t need new ways to evaluate how drug company mergers affect innovation.
04/27/2022
 
 
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
 
 
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