Federal Register notice: FDA proposes to establish criteria for the lists of drug products or drug categories that present demonstrable difficulties f...
FDA approves Johnson & Johnsons Edurant PED (rilpivirine) for treating HIV-1 in combination with other antiretroviral therapies in treatment-nave chil...
FDA asks the Ophthalmic Devices Panel to discuss safety and other issues related to the Balance Ophthalmics FSYX ocular pump to lower intraocular pres...
FDA reports the key themes that emerged from a 3/2023 virtual meeting with patients and caregivers on long Covid.
CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and conflate product benefits and risks when exposed t...
FDA solicits applications for grants to explore the role of digital health technologies in evaluating new drugs.
FDA proposes to evaluate drugs and categories of drugs that present demonstrable difficulties for compounding and place three categories on the lists.
Two U.S. House lawmakers introduce a bipartisan bill to create an emergency supply of active pharmaceutical ingredients (APIs) used in essential gener...