FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Government Turns to High Court in Mifepristone Appeal

The Justice Department seeks emergency relief from the U.S. Supreme Court after the Fifth Circuit Court of Appeals ruled that the abortion drug mifepr...

latest-news-card-1
Federal Register

Guide on OTC Monograph Order Requests

Federal Register notice: FDA makes available a draft guidance entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content.

latest-news-card-1
Federal Register

Input Sought on FDA Tech/Data Strategic Plan

Federal Register notice: FDA announces a request for information and comments on the development of an FDA data and technology strategic plan.

latest-news-card-1
Human Drugs

Panels to Consider Rexulti sNDA for Alzheimers Agitation

FDA medical reviewers ask two advisory committees to consider whether there is a population of Alzheimers patients for whom Otsuka and Lundbecks Rexul...

latest-news-card-1
Human Drugs

Texas House Approves Drug Import Bill

The Texas House approves a bill to establish a state program that would allow the importation of some drugs from Canada.

latest-news-card-1
Federal Register

Guide on Clinical Trial Monitoring

Federal Register notice: FDA makes available a final guidance entitled A Risk- Based Approach to Monitoring of Clinical Investigations Questions and ...

latest-news-card-1
Federal Register

Pilot Program on Radiation Sterilization Master Files

Federal Register notice: CDRH announces its Radiation Sterilization Master File Pilot Program, a voluntary program for companies that terminally steri...

latest-news-card-1
Human Drugs

Format/Content of OTC Monograph Order Request

FDA publishes a draft guidance recommending the content and format for submitting OTC monograph order requests to the agency.

latest-news-card-1
Federal Register

Meeting on User Fee Programs Financial Transparency

Federal Register notice: FDA plans a 6/8 public meeting entitled Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimil...

latest-news-card-1
Human Drugs

Assessing Adhesion with Transdermal Systems

FDA publishes a draft guidance recommending the design and conduct of studies evaluating the adhesion performance of a transdermal or topical drug del...