FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

Nitrosamine Control Guidance Out

FDA issues a guidance to help manufacturers prevent unacceptable levels of nitrosamines in all chemically synthesized drugs.

Human Drugs

Hahn Should Tell Truth or Resign: Topol

Scripps Research Translational Institute director Eric Topol writes an open letter to FDA commissioner Stephen Hahn asking him to hold a press confere...

Human Drugs

Dont Let Orange Book Block Competition: 23 AGs

Twenty-three attorneys general ask FDA not to allow branded drug companies to list device and component patents in the Orange Book as a way to speed g...

Federal Register

Regulatory Review Period for Lumoxiti

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Innate Pharmas Lumoxiti.

Federal Register

Info Collection on Biologic Adverse Experience Reporting

Federal Register notice: FDA seeks comments on an information collection extension for Adverse Experience Reporting For Licensed Biological Products; ...

Human Drugs

FDA May Give EUA for Covid Vaccine on Early Data: Hahn

FDA commissioner Stephen Hahn says it is possible that an emergency use authorization for a Covid-19 vaccine could be granted before Phase 3 clinical ...

Federal Register

Guide on Device Patient-reported Outcomes Usage

Federal Register notice: FDA makes available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported ...

Federal Register

OMB Approves Eight Information Collections

Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.

Federal Register

FDA Releases Draft Bioequivalence ANDA Guides

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on the design of bioequivalence studies to ...

Human Drugs

FDA Approves Innocoll NDA for Xaracoll

FDA approves an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up to 24 hours in adults...