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Welcome to FDAweb Pay Per View Search our 72,348 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 Next >>   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     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     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     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     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     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     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     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     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     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     << Prev  36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55  Next >>

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