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TXT FDA Encouraging ‘Advanced Manufacturing’ [2750 Words] [ Price : $8.95]
FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah describe agency steps to promote advanced manufacturing for drugs, biologics, and medical devices.
08/04/2020
 
 
TXT GSK, Sanofi Report Zantac-related Probes [319 Words] [ Price : $8.95]
GlaxoSmithKline (XXX DELETE XXX)and Sanofi separately disclose that they are being investigated by the U.S. Justice Department over alleged False Claims Act violations related to the companies’ marketing and subsequent recall of heartburn drug Zantac.
08/04/2020
 
 
TXT Ex-FDA Commissioners Urge Coordinated Covid-19 Plasma Effort [368 Words] [ Price : $8.95]
Four former FDA commissioners urge U.S. regulators, researchers and Covid-19-recovered patients to join in an effort to collect blood plasma and begin clinical trials to determine whether the plasma from recovered patients can help those who become sick.
08/04/2020
 
 
TXT Biosimilar User Fee Rates for FY 2021 [69 Words] [ Price : $8.95]
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2021.
08/04/2020
 
 
TXT Latest FDA Warning Letters [496 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Acrx Specialty Pharmacy, Fishman Chemical and MMSTabs.com.
08/04/2020
 
 
TXT Drug User Fee Rates for FY 2021 [74 Words] [ Price : $8.95]
Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2021.
08/03/2020
 
 
TXT Device User Fees for FY 2021 [71 Words] [ Price : $8.95]
Federal Register notice: FDA announces the fee rates and payment procedures for medical device user fees for fiscal year 2021.
08/03/2020
 
 
TXT Guide on Pediatric Study Plans [81 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.”
08/03/2020
 
 
TXT Available Guidances Related to Covid-19 [69 Words] [ Price : $8.95]
Federal Register notice: FDA makes available guidance documents related to Covid–19 public health emergency.
08/03/2020
 
 
TXT Comments Sought on Generics Fee Report [90 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on a report entitled “Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology.”
08/03/2020
 
 
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