FDA continues making progress on bulk drug substances for compounding
Category Archives: Drug Safety Information Podcasts
Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed
The FDA responds to Bayer’s announcement to halt Essure sales in the US
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation
FDA approves new drug for the treatment of adults with acute myeloid leukemia who have a specific genetic mutation and a companion diagnostic to detect specific mutations in the IDH1 gene in patients with AML
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.
Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA
Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA
Statement by FDA Commissioner Scott Gottlieb, M.D., on the formation of a new work group to develop focused drug importation policy options to address access challenges related to certain sole-source medicines with limited patient availability, but no blocking patents or exclusivities
FDA forms work group on drug importation policy options to address certain patient access challenges
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan
FDA releases Biosimilars Action Plan to address competition and affordability for biologics and biosimilar products.
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
New York-based food processors agree to stop food preparation operations due to food safety violations
New York-based food processors agree to stop food preparation operations due to food safety violations
Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs
FDA describes innovative approaches to increase access to a broader selection of nonprescription drug products for consumers