Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient...
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher...
FDA approves the first generic version of EpiPen and EpiPen Jr for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.
This page contains the Pulmonary-Allergy Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee.
A cost-effectiveness analysis of the FDA’s “The Real Cost” youth smoking prevention campaign shows it has resulted in savings of more than $31 billion for youth, their families and society at large.
Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein...
Marsee Foods, Inc. dba Marsee Baking is voluntarily recalling chocolate chip, ginger spice, and oatmeal raisin cookies sold at Café Yumm! restaurants. The cookies may contain undeclared peanuts. People who have an allergy or severe...
Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide in support of responsible opioid prescribing for safe, effective pain management in animals
Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or...
We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at...
Today is Day 2 of the Pediatric Medical Device Public Meeting. Today we will be discussing the importance of International Regulation Harmonization. https://go.usa.gov/xU6rg # Devices4Kids # MedicalDevice pic.twitter.com/bMYgjX8CTX
We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today....
FDA Commissioner, @ SGottliebFDA , speaking during day 1 of the Pediatric Medical Device Development Public Meeting # devices4kids # FDA # MedicalDevice pic.twitter.com/0I1Poe9Yqn
World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend...
More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. # devices4kids #...
Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed # digitalhealth and how technology enables development and access to safe medical devices # devices4kids # FDAPreCert...
Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the # FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg #...
By: Scott Gottlieb, M.D., and Mitch Zeller, J.D. This summer marks nine years since the Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law, and one year since we announced the FDA’s Comprehensive Plan for Tobacco...
Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as...
FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for...
Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery https://go.usa.gov/xUHgr # fda # medicaldevice
FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA...
The app uses basal body temperature readings to predict when a woman is most fertile to help her avoid conceiving on those days if using as a form of contraception
FDA is alerting pet owners and veterinary professionals about reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients.
As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of...
Country Favor Inc. of Maspeth, New York is recalling its 7 ounce packages of “Best Taste Brand Snack Ginger Sliced” food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of...