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TXT FDA Agrees with Consultants on Covid Test EUAs [2744 Words] [ Price : $8.95]
FDA agrees with Booz Allen Hamilton recommendations to improve the CDRH effort to issue emergency use authorizations for tests during a public health emergency.
10/13/2021
 
 
TXT FDA Won’t Enforce ID Submission for Some Class 1 Devices [2737 Words] [ Price : $8.95]
FDA says it does not plan to enforce universal device identification submission requirements for some devices it considers to be Class 1 consumer health products.
10/13/2021
 
 
TXT CDER Emerging Technology Program Expanding [2786 Words] [ Price : $8.95]
CDER leaders say they are expanding Center efforts to promote advanced manufacturing techniques for drugs.
10/13/2021
 
 
TXT FDA Approves Lilly’s Verzenio Breast Cancer Drug [2629 Words] [ Price : $8.95]
FDA approves Lilly’s Verzenio CDK4/6 inhibitor for certain breast cancer patients as determined by an FDA-approved diagnostic test.
10/13/2021
 
 
TXT FDA Questions J&J Covid Vaccine Booster Data [2753 Words] [ Price : $8.95]
FDA tells its Vaccines and Related Biological Products Advisory Committee it has some concerns about data submitted by J&J in support of a booster shot of its Covid-19 vaccine.
10/13/2021
 
 
TXT Keytruda Plus Chemo Approved for Cervical Cancer [170 Words] [ Price : $8.95]
FDA approves Merck’s Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1.
10/13/2021
 
 
TXT Some Class 1 Devices Exempt from UDI [81 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.
10/13/2021
 
 
TXT Guide on Drug Continuous Manufacturing [71 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Products.
10/13/2021
 
 
TXT Revance Therapeutics FDA-483 Released [2706 Words] [ Price : $8.95]
FDA releases the FDA-483 with five inspection observations issued following an inspection at Revance Therapeutics.
10/13/2021
 
 
TXT Otsuka/H. Lundbeck sNDA for Rexulti in Adolescents [168 Words] [ Price : $8.95]
FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in adolescents.
10/13/2021
 
 
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