FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Latest Federal Register Notices
FDA Review posts the latest Federal Register Notices for the week ending 1/13/2017.
FDA General
Alliance Sees Battles Ahead for FDA Funding
The Alliance for a Stronger FDA foresees funding battles for the agency as the incoming Trump Administration looks at deficit reductions through cuts ...
Medical Devices
Fujifilm Medical Removing Older Duodenoscopes from Market
FDA says Fujifilm Medical Systems decides to remove from the market older models (250/450) duodenoscopes based on the limited number currently in use.
Federal Register
Comments Sought on Combination Product Policies
Federal Register Notice: FDA establishes a docket to receive comments about policy issues that may be considered by the FDA Combination Product Policy...
Federal Register
Comments Sought on Rapid Response Surveys
Federal Register Notice: FDA seeks comments on an information collection extension related to its use of rapid response surveys.
Federal Register
Guide on Comparative Analyses for Generic Combination Products
FDA posts a draft guidance on Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted i...
Medical Devices
FDA Discussion Paper on New LDT Oversight Proposal
An FDA discussion paper on laboratory developed tests outlines a new proposal to provide oversight of such devices.
Federal Register
Guide on Emergency Use Authorizations
Federal Register Notice: FDA makes available a guidance on Emergency Use Authorization of Medical Products and Related Authorities.
Human Drugs
Draft Guide on Referencing Approved Products in ANDAs
FDA posts a draft guidance on Referencing Approved Drug Products in ANDA Submissions that provides information to potential applicants on how to ident...
