FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

Friends of Cancer Research Cautions on Right-to-Tryֹ

An online post from Friends of Cancer Research chair and founder Ellen V. Sigal says that pending right-to-try legislation in Congress is an ill-advis...

Human Drugs

Otonomy NDA for Swimmers Ear Approved

FDA approves an Otonomy NDA for Otiprio (ciprofloxacin otic suspension) 6% for treating acute otitis externa (swimmers ear) caused by Pseudomonas aeru...

Federal Register

Draft Guide on Drug Supply Definitions

Federal Register notice: FDA makes available a draft guidance entitled Definitions of Suspect Product and Illegitimate Product for Verification Obliga...

Federal Register

Comments Sought on Pediatric Drug Safety Reviews

Federal Register notice: FDA seeks comments on post-marketing pediatric-focused safety reviews of products posted between 10/23/2017 and 3/16 on its W...

Human Drugs

FDA Lauds its Success in Accelerated Cancer Drug OKs

An FDA review of cancer drugs that used the accelerated approval program finds that very few of the resulting indications failed to verify clinical be...

Federal Register

Latest Federal Register Notices

FDA Review posts the latest Federal Register notices for the week ending 3/2/2018.

Federal Register

Draft Guide on Product Tracing Standardized Data

Federal Register notice: FDA makes available a draft guidance on Standardization of Data and Documentation Practices for Product Tracing.

Federal Register

Guide on Genomic Sampling and Managing Data

Federal Register notice: FDA makes available a guidance entitled E18 Genomic Sampling and Management of Genomic Data.

Human Drugs

Jazz Pharma NDA for Sleep Disorders Under Review

FDA accepts for review a Jazz Pharmaceuticals NDA for solriamfetol, an investigational medicine for treating excessive sleepiness in adult patients wi...

Federal Register

FDA/Canada Joint ICH Regional Meeting

Federal Register notice: FDA announces a regional public meeting entitled U.S. Food and Drug Administration and Health Canada Joint Regional Consultat...