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TXT Groups Suggest Changes to Device Quality System Reg [2824 Words] [ Price : $8.95]
Four medical device stakeholders voice general support for an FDA proposal to harmonize the medical device Quality System Regulation with an international standard.
05/24/2022
 
 
TXT CDER Research Helping Generic Inhaler Development [2747 Words] [ Price : $8.95]
CDER researchers describe a study of mouth-throat models for generic metered-dose inhalers to help generic inhaler manufacturers more efficiently test their products.
05/23/2022
 
 
TXT Teva Recalls 1 Lot of Anagrelide Capsules [2625 Words] [ Price : $8.95]
FDA says Teva recalled one lot of anagrelide capsules due to dissolution test failure.
05/23/2022
 
 
TXT Guide on Non-inferiority Trials for Antibacterials [212 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases — Questions and Answers (Revision 1).”
05/23/2022
 
 
TXT Guide on Drug Shortage Risk Management Plans [98 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Risk Management Plans to Mitigate the Potential for Drug Shortages.”
05/23/2022
 
 
TXT Medical Gas GMP Requirements Amended [42 Words] [ Price : $8.95]
Federal Register notice: FDA proposes new regulations that would amend the requirements on current good manufacturing practices and postmarketing safety reporting that apply to certain medical gases.
05/23/2022
 
 
TXT GI Advisory Committee Renewal Notice Correction [47 Words] [ Price : $8.95]
Federal Register notice: FDA corrects a 5/11 notice entitled “Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal.”
05/23/2022
 
 
TXT More Women Participating in Clinical Trials: Report [2782 Words] [ Price : $8.95]
FDA principal deputy commissioner Janet Woodcock and two other FDAers praise agency efforts to increase participation of women in clinical trials and pledge further work to bridge gaps in representation.
05/23/2022
 
 
TXT FDAers Discuss PBBM Overview and Future [2712 Words] [ Price : $8.95]
Three FDAers and a drug researcher give an overview of physiologically-based biopharmaceutics modeling.
05/23/2022
 
 
TXT ImmunityBio BLA for Bladder Cancer Therapy [177 Words] [ Price : $8.95]
ImmunityBio files a BLA for N-803, which it describes as a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ.
05/23/2022
 
 
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