Archive for the ‘Food Safety News’ category

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

July 31, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

FDA approves first treatment for rare adrenal tumors

July 30, 2018

FDA approves first treatment for rare adrenal tumors

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”

July 30, 2018

FDA warns doctors and patients about deceptive claims on laser medical devices used to treat menopausal symptoms for “vaginal rejuvenation”

Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products

July 26, 2018

Process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

July 24, 2018

The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

July 24, 2018

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

July 23, 2018

FDA continues making progress on bulk drug substances for compounding

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

July 20, 2018

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

July 20, 2018

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

July 20, 2018

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

July 19, 2018

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

July 19, 2018

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

July 18, 2018

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

July 18, 2018

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

July 17, 2018

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

July 17, 2018

FDA describes innovative approaches to increase access to a broader selection of nonprescription drug products for consumers

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

July 13, 2018

FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure

FDA approves the first drug with an indication for treatment of smallpox

July 13, 2018

FDA today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox.

FDA warns of imposters sending consumers fake warning letters

July 13, 2018

FDA is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.

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