FDA Related News

Medical Devices

Siemens Somatom Mobile CT Scanner Cleared

FDA clears a Siemens Healthineers 510(k) for the Somatom On.site, a mobile head computed tomography scanner.

Biologics

AbbVie Ends Voyager Therapy Development Pact

Voyager Therapeutics says AbbVie has ended two agreements under which Voyager was to research and develop treatments for Alzheimers, Parkinsons, and o...

Human Drugs

Rare Disease Clinical Trial Networks

Three industry and patient stakeholders express support for the creation of one or more rare disease clinical trial networks.

Federal Register

Combo Product Constituent Part Applicant Info Collection

Federal Register notice: FDA sends to OMB an information collection extension for Postmarketing Information Sharing Among Constituent Part Applicants ...

Federal Register

Combo Products Office Pilots eSubmission Process

Federal Register notice: FDA seeks applicants to participate in an Office of Combination Products voluntary pilot program to help it evaluate a new el...

Federal Register

FT 2021 User Fee Rates for Outsourcing Facilities

Federal Register notice: FDA announces fiscal year 2021 user fee rates for the establishment and re-inspection fees for entities that compound human d...

Comments on FDA Data Strategy Modernization

Four stakeholders comment on early FDA plans to modernize its data strategy.

Human Drugs

MasterPharm FDA-483 Released

FDA releases an FDA-483 with seven observations from its inspection at MasterPharm, a producer of sterile and non-sterile drug products.

Human Drugs

Drug Limited Population Pathway Guidance

FDA publishes a guidance explaining its implementation of a 21st Century Cures provision creating a limited population pathway for new antibacterial a...

Federal Register

Drug User Fee Rates for FY 2021

Federal Register notice: FDA sets the rates for generic new animal drug user fees for fiscal year 2021.