FDA Related News

Human Drugs

FDA Approves Imbruvica and Rituximab for Rare Disease

FDA approves Janssen Biotech and Pharmacyclics Imbruvica (ibrutinib) in combination with Genentechs rituximab for treating Waldenstrm's macroglobuline...

Medical Devices

CathWorks 510(k) for Fractional Flow Reserve Device

CathWorks files a 510(k) for its CathWorks FFRangio System, a fractional flow reserve device that is intended to deliver objective multi-vessel physio...

Medical Devices

Warning Letter Sent to Zimmer Biomet Subsidiary

FDA 8/24 sends a Warning Letter to a Zimmer Biomet subsidiarys manufacturing facility in Warsaw, IN over GMP issues documented in an April inspection....

Pfizer Petitions FDA for Guidance on Biosimilar Communications

Pfizer petitions FDA to issue a guidance document to clarify appropriate sponsor communications about the nature and properties of biosimilar products...

Human Drugs

Latest Federal Register Notices

FDA Review post the Federal Register notices for the week ending 8/24/2018.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 8/3/2018.

Federal Register

Pharmaceutical Quality Site Visit Program

Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Progra...

Federal Register

Plasma Lyte Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Plasma Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for reasons of safety o...

Federal Register

Guide on Hematologic Malignancy and Oncologic Drug Trials

Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebo...

Human Drugs

Appeals Court Reverses GSK $3 Million Liability Suit

The U.S. Court of Appeals for the Seventh Circuit reverses a lower court decision and $3 million verdict in a product liability that attempted to hold...