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TXT CDER Compliance Priorities Include Covid, Opioids Focus [346 Words] [ Price : $8.95]
CDER’s Office of Compliance (OC) says its priorities for 2022 include supporting FDA’s Covid-19 response , reducing harm caused by opioid crisis, and improving the agency’s oversight of drug compounding operations.
04/29/2022
 
 
TXT Crohn’s Disease Draft Guidance Released [82 Words] [ Price : $8.95]
FDA posts a draft guidance entitled Crohn’s Disease: Developing Drugs for Treatment that discusses clinical trial considerations.
04/29/2022
 
 
TXT Gilead Sciences Gets Priority Voucher for Veklury [67 Words] [ Price : $8.95]
Federal Register notice: FDA issues a priority review voucher to Gilead Sciences under the agency’s material threat medical countermeasure program.
04/29/2022
 
 
TXT Clinical Hold Lifted on Finch C-diff Therapy [287 Words] [ Price : $8.95]
FDA lifts a clinical hold on a Finch Therapeutics Group IND for CP101, an orally administered microbiome therapeutic which is in late-stage clinical development for preventing recurrent C. difficile infection.
04/29/2022
 
 
TXT 5 Tentative Dates for Covid Vaccine Panel Reviews [216 Words] [ Price : $8.95]
FDA announces the tentative Vaccines and Related Biological Products Advisory Committee schedule that has five separate dates the panel will meet to review and discuss emergency use authorization submissions for Covid-19 vaccines.
04/29/2022
 
 
TXT Guide on Ulcerative Colitis Drugs [94 Words] [ Price : $8.95]
FDA posts a draft guidance entitled Ulcerative Colitis: Developing Drugs for Treatment.
04/29/2022
 
 
TXT FDA Updates Digital Health Policy Document [2641 Words] [ Price : $8.95]
FDA updates its Digital Health Policies Web page to include new information from the Covid-19 public health emergency.
04/28/2022
 
 
TXT Cupric Sulfate Not Withdrawn Due to Safety/Efficacy [88 Words] [ Price : $8.95]
Federal Register notice: FDA determines that Abraxis Pharmaceutical’s cupric sulfate injection was not withdrawn from sale for reasons of safety or effectiveness.
04/28/2022
 
 
TXT Pharma Science/Clin Pharm Panel Renewed [65 Words] [ Price : $8.95]
Federal Register notice: FDA renews the charter of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years.
04/28/2022
 
 
TXT Guide on Postmarketing Safety eSubmissions [85 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Providing Submissions in Electronic Format — Postmarketing Safety Reports.
04/28/2022
 
 
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