FDA Related News

Human Drugs

FDA Issues Product-Specific Generic Drug Guidances

FDA touts publication of 57 new and revised product-specific guidances to help generic drug makers know what is required to obtain ANDA approval for a...

Human Drugs

United Therapeutics Submits 5th Tyvaso Petition

United Therapeutics submits a fifth petition on its Tyvaso to ensure that FDA considers the issues the company has raised.

Human Drugs

FDA Rejects Sandoz Proposed Generic Advair

FDA sends Sandoz a complete response letter, denying approval for its proposed generic copy of GlaxoSmithKlines Advair Diskus (fluticasone propionate/...

Human Drugs

Novartis Gains Expanded Label for Cosentyx

FDA approves a Novartis supplemental BLA for Cosentyx (secukinumab) to update its label to include moderate-to-severe scalp psoriasis.

Medical Devices

Mesa Biotech Gains Clearance for Flu Test

FDA clears a Mesa Biotech 510(k) for its Accula Flu A/Flu B test for use on the companys polymerase chain reaction testing platform.

Medical Devices

Court Upholds Device Exempt, Implied Preemption

Attorney Elizabeth Minerd praises an Illinois federal court for taking the time to carefully analyze a number of allegations in a medical device case ...

Human Drugs

High Court Asked to Consider Gilead Case

Washington Legal Foundation asks the Supreme Court to overturn an appeals court ruling in a Gilead whistleblower case.

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...