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Federal Register

Workshop Transcript on Cell Therapy Workshop

Federal Register notice: FDA corrects a 12/29/2016 notice about a public workshop entitled Identification and Characterization of the Infectious Disea...

Federal Register

Comments Sought on Device Corrections and Removals Reporting

Federal Register notice: FDA seeks comments on a information collection extension entitled Medical Devices; Reports of Corrections and Removals 21 CF...

Federal Register

FDA Delays for 1 Year Intended Use Final Rule

Federal Register Notice: FDA delays until 3/19/2018 the effective date of its final rule on Clarification of When Products Made or Derived From Tobacc...

Federal Register

Latest Federal Register Notices

FDA Review posts Federal Register notices for the week ending 3/17/2017.

Federal Register

Comments Sought on Pharmacogenomic Data Submissions

Federal Register Notice: FDA seeks comments on an information collection extension for its Guidance for Industry on Pharmacogenomic Data Submissions....

Federal Register

Comments Sought on 510(k) Cover Sheet

Federal Register Notice: FDA seeks comments on an information collection reinstatement for Premarket Notification21 CFR Part 807, Subpart E.

Federal Register

Comments Sought on Device Pediatric Use Information

Federal Register Notice: FDA seeks comments on an information collection extension for its guidance on Providing Information About Pediatric Uses of M...

Medical Devices

FDA Clears Teleflex Twin-Pass Dual Access Catheter

FDA clears a Teleflex 510(k) for the Twin-Pass Torque Dual Access Catheter, which is designed for procedures that call for the delivery of two interve...

Federal Register

Draft Guide on Generic Rifaximin Bioequivalence

FDA makes available a revised draft guidance for industry on generic rifaximin oral tablets and bioequivalence issues.

Human Drugs

CEL-SCI Gets Minutes on Clinical Hold FDA Meeting

CEL-SCI Corp. receives the official FDA minutes from a 2/8 meeting that discussed a partial clinical hold placed 9/2016 on a Phase 3 head and neck can...