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TXT Drug Compounding Information Collection Revision [79 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision entitled “Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.”
06/17/2022
 
 
TXT Info Collection on Influenza A Reagents Guide [139 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866.”
06/17/2022
 
 
TXT Bill Would Establish FDA/USPTO Patent Task Force [263 Words] [ Price : $8.95]
Sens. Dick Durbin (D-IL), chair of the Senate Judiciary Committee, ranking member Chuck Grassley (R-IA) and Thom Tillis (R-NC) introduce bipartisan legislation that would establish a task force between the U.S. Patent and Trademark Office and FDA to improve communication and coordination in implementing each agency’s activities related to patents.
06/17/2022
 
 
TXT Guide on Power Morcellator Containment Systems [114 Words] [ Price : $8.95]
CDRH makes available a draft guidance on Power Morcellator containment systems’ clinical performance assessments.
06/17/2022
 
 
TXT Act on Medical Dye Shortage: 30 GOP Representatives [155 Words] [ Price : $8.95]
Some 30 GOP House members call on President Biden to take steps to alleviate a shortage of intravenous contrast agents.
06/16/2022
 
 
TXT FDA Updates Off-Patent, Off-Exclusivity List [147 Words] [ Price : $8.95]
FDA publishes the latest update for its list of off-patent, off-exclusivity drugs for which there are no approved generics.
06/16/2022
 
 
TXT Guide on Quantitative Imaging Device Filings [76 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled “Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions.”
06/16/2022
 
 
TXT Central Admixture Pharmacy FDA-483 [197 Words] [ Price : $8.95]
FDA releases the FDA-483 with six observations from an inspection at Phoenix, AZ-based Central Admixture Pharmacy Services.
06/16/2022
 
 
TXT Merck Keytruda sBLA for Non-small Cell Lung Cancer [181 Words] [ Price : $8.95]
FDA accepts for review a Merck supplemental BLA seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patients with Stage IB, II or IIIA non-small cell lung cancer following complete surgical resection.
06/16/2022
 
 
TXT Stakeholders Seek Changes in CAR-T Draft Guidance [420 Words] [ Price : $8.95]
Five stakeholders recommend changes and clarifications to an FDA draft guidance on CAR-T cell product development.
06/16/2022
 
 
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