FDA Related News

Human Drugs

Transactional Science Role for NIH: Woodcock

CDER director Janet Woodcock urges the National Institutes of Health to take on research into translational science that can help lower the cost of dr...

Human Drugs

FDA OKs Helix L-DOS47 Study in Pancreatic Cancer

FDA authorizes a Helix BioPharma IND to begin a Phase 1b/2 study of L-DOS47 and doxorubicin in patients with advanced metastatic pancreatic cancer.

Human Drugs

Erroneous Adverse Event Report Doesnt Stop Study: Sarepta

Sarepta says an erroneous adverse event report in a study of a Duchenne muscular dystrophy gene therapy candidate did not interrupt the study.

Federal Register

Info Collection on IVD Study Informed Consent

Federal Register notice: FDA sends to OMB an information collection extension for its guidance on informed consent for in vitro diagnostic device stud...

Human Drugs

AveXis Inspection Observations

FDA releases the FDA-483 with five inspection observations issued following an inspection at the AveXis control testing laboratory.

Biologics

CBER FY 2018 Product Deviation Reports

CBER releases its summary deviations report for FY 2018 covering biological products and HCT/Ps.

Human Drugs

Panel Backs Descovy for Preventing HIV in Men

An FDA advisory committee has voted 16-2 to recommend approval for Gilead Sciences HIV drug Descovy for pre-exposure prophylaxis (PrEP) in men and tra...

Human Drugs

Grassley Wants Unannounced Foreign Drug Inspections

Sen. Grassley asks FDA to resume unannounced inspections at foreign drug manufacturing facilities.

Human Drugs

Fabry Disease Drug Development Guidance

FDA issues a draft guidance on developing drugs to treat Fabry Disease.

FDA to Research Provider Boxed Warning Perceptions

CDERs Office of Prescription Drug Promotion says it will survey healthcare providers to learn how they receive, process, and use Boxed Warning and oth...