HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS

Welcome to FDAweb Pay Per View Search our 70,569 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers            1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   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     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     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     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     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     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     Some Class 1 Devices Exempt from UDI [81 Words] [ Price : $8.95] Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.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     Guide on Drug Continuous Manufacturing [71 Words] [ Price : $8.95] Federal Register notice: FDA makes available a draft guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Products. 10/13/2021     Revance Therapeutics FDA-483 Released [2706 Words] [ Price : $8.95]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     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       1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com