FDA Related News

Human Drugs

Emergent BioSolutions EIR and FDA-483

FDA releases an FDA-483 and EIR from a 2019 inspection at Winnipeg, Manitoba-based Emergent BioSolutions Canada.

Human Drugs

Hopkinton Drug Notice of Violation

FDA cautions Hopkinton Drugs about deficiencies in its practices for producing drug products that put patients at risk.

Federal Register

Meeting on Drug eSubmissions and Data Standards

Federal Register notice: FDA announces a 4/12 virtual public meeting entitled Prescription Drug User Fee Act of 2017; Electronic Submissions and Data ...

Federal Register

FDA Adds 4 Bulk Drug Substances to Compounding List

Federal Register notice: FDA evaluates certain substances that have been nominated for inclusion on a drug compounding list of bulk drug substances fo...

Human Drugs

FDA Inspection Efficiency Measure Drops

FDA says the pandemic affected its ability to complete regulatory actions for inspected facilities within six months of the inspection closing during ...

FDA General

Former FDA Digital Health Guru Joins Big Health

Former FDA deputy commissioner for medical and scientific affairs Anand Shah joins Big Healths board of directors.

FDA General

Hogan Lovells Hires Former FDA Investigator

Law firm Hogan Lovells hires former FDA investigator Chris Middendorf as the firms regulatory affairs director.

FDA Responsibilities in New Preparedness Bill

FDA would have many responsibilities under bipartisan legislation drafted to improve the nations pandemic and public health preparedness released by S...

Federal Register

Device Guide on Patient-Reported Outcome Instruments

Federal Register notice: FDA makes available a medical device final guidance on principles for using patient-reported outcome instruments.

Federal Register

Guide on Patient Engagement in Device Trial Designs

Federal Register notice: FDA makes available a final guidance entitled Patient Engagement in the Design and Conduct of Medical Device Clinical Studies...