FDA Related News

Federal Register

FDA Adds 4 Tropical Disease Designations

Federal Register notice: FDA determines that chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis satisfy its tropical disease ...

Federal Register

Pneumocystis Pneumonia Not a Tropical Disease: FDA

Federal Register notice: FDA determines that Pneumocystis pneumonia does not meet statutory criteria for designation as a tropical disease.

Human Drugs

FDA Proposes Banning 3 Bulk Drugs from Compounding

FDA proposes to ban three bulk drug substances bumetanide, nicardipine hydrochloride, and vasopressin from its list of bulk drug substances (active ...

Human Drugs

Problems Seen in Draft Pressor Effect Guidance

Stakeholders ask for clarifications to an FDA draft guidance on assessing drugs pressor effects.

FDA General

Data-Driven Psychiatry Possible: Study

Former FDA commissioner Robert Califf and Verily Life Sciences researchers suggest it is possible to use digital measurement tools and analytics to mo...

Human Drugs

Shires Takhzyro Approved for Hereditary Angioedema

FDA approves a Shire BLA for Takhzyro (lanadelumab-flyo) injection for preventing hereditary angioedema attacks in patients 12 years of age and older.

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...