The FDA responds to Bayer’s announcement to halt Essure sales in the US
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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
H-E-B Voluntarily Issues Recall Two Variety Packs of Creamy Creations Ice Creams and Sherbets in 3-Ounce Cups Recalled due to Broken Metal in Processing Equipment
H-E-B is voluntarily issuing a recall for two variety packs of Creamy Creations ice cream and sherbets in 3-ounce cups due to broken metal found in processing equipment during routine maintenance. The potentially affected products were distributed only to H-E-B stores in Texas. Please note, the product was not distributed to the Houston area or Mexico.
Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns
Portland French Bakery of Portland, OR is recalling 26,635 units of Seattle Sourdough Pub Bun 6pk and 8,022 units of Franz Premium Pub Buns 12pk, because it may contain undeclared SOY. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
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
Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses
WEST DES MOINES, Iowa (July 17, 2018) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its Hy-Vee Spring Pasta Salad due to the potential that it may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention last night when approximately 20 illnesses in Minnesota, South Dakota, Nebraska and Iowa were potentially linked back to customers consuming the salad. The voluntary recall includes Hy-Vee Spring Pasta Salads in both 1 pound (16 oz.) and 3 pound (48 oz.) containers produced between June 1, 2018, and July 13, 2018, and available from the deli service case.