FDA Related News

Federal Register

Criteria on Difficult Compounding Lists

Federal Register notice: FDA proposes to establish criteria for the lists of drug products or drug categories that present demonstrable difficulties f...

Human Drugs

J&Js Edurant PED Approved for Pediatric HIV-1

FDA approves Johnson & Johnsons Edurant PED (rilpivirine) for treating HIV-1 in combination with other antiretroviral therapies in treatment-nave chil...

Medical Devices

Panel to Discuss Non-invasive Ocular Pump

FDA asks the Ophthalmic Devices Panel to discuss safety and other issues related to the Balance Ophthalmics FSYX ocular pump to lower intraocular pres...

Human Drugs

Key Patient Long Covid Meeting Themes

FDA reports the key themes that emerged from a 3/2023 virtual meeting with patients and caregivers on long Covid.

Human Drugs

FDA Warning Letters on Chinese Syringes

FDA sends Warning Letters to Jiangsu Shenli Medical Production Co. Ltd, a China-based plastic syringe manufacturer, and Medline Industries and Sol-Mil...

Human Drugs

FDA OKs Chronic Rhinosinusitis Nasal Spray

FDA approves an Optinose NDA for Xhance (fluticasone propionate) nasal spray for treating chronic rhinosinusitis without nasal polyps in patients 18 y...

Marketing

Disease Awareness Ads Can Confuse: FDA Study

CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and conflate product benefits and risks when exposed t...

Digital Health Research Grants Available

FDA solicits applications for grants to explore the role of digital health technologies in evaluating new drugs.

Human Drugs

FDA to Make Compounding Difficulty Lists

FDA proposes to evaluate drugs and categories of drugs that present demonstrable difficulties for compounding and place three categories on the lists.

Human Drugs

Bipartisan Bill to Shore Up Emergency APIs

Two U.S. House lawmakers introduce a bipartisan bill to create an emergency supply of active pharmaceutical ingredients (APIs) used in essential gener...