FDA Related News

Human Drugs

Listing Updated on Pharmacogenomic Biomarkers in Drug Labeling

FDA updates a public listing of Pharmacogenomic Biomarkers in Drug Labeling.

Federal Register

Regulatory Review Determined for Jublia

Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Kaken Pharmaceutical Co.s Jublia (efinacon...

Stakeholders Praise Intended Use Rule Delay

Four key stakeholders praise FDA for delaying indefinitely implementation of its final rule giving a new definition for intended use of medical produc...

Human Drugs

FDA Posts Impurity Data Considerations

FDA posts considerations for applicants to consider when deciding when to submit elemental impurity data to the agency.

Federal Register

Regulatory Review For AstraZenecas Farxiga

Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for AstraZenecas Farxiga (dapagliflozin) is 3,...

Federal Register

Regulatory Review for Gileads Genvoya

Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Gilead Sciences Genvoya is 5,031 days.

Federal Register

Regulatory Review for Sedasys System

Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Scott Laboratories Sedasys System is 2,816...

Human Drugs

Gottlieb Outlines New Efforts on Biosimilars, OTC Drugs and Opioids

During a 2/6 address to the Alliance for a Stronger FDA, commissioner Scott Gottlieb discusses new efforts on biosimilar competition, OTC drug product...

Medical Devices

Partial Summary Judgment OKd in Medtronic Pump Case

A DC federal court has granted Medtronic and Unomedical summary judgment on several courts in complex litigation involving a Medtronic pump and infusi...

Medical Devices

Pentax Recalls Duodenoscopes to Replace Parts

FDA says Pentax has recalled duodenoscopes to replace several parts to improve reprocessing effectiveness.