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News & Events

Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

Tue, 2019-06-18 13:44
FDA is enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity).

Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

Tue, 2019-06-18 10:44
This is a statement regarding the FDA’s new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products.

FDA approves new treatment for pediatric patients with type 2 diabetes

Mon, 2019-06-17 16:34
: FDA approves Victoza (liraglutide) injection for pediatric patients with type 2 diabetes. Victoza creates the same effect as GLP-1 receptor protein and is the first non-insulin drug approved since metformin in 2000.

Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

Fri, 2019-06-14 16:20
Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

Tue, 2019-06-11 16:02
FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes

Tue, 2019-06-11 10:01
FDA finalizes guidance for manufacturers submitting premarket tobacco product applications for electronic nicotine delivery systems, such as e-cigarettes or “vapes.”

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Mon, 2019-06-10 12:59
FDA approved Polivy in combination with the chemotherapy bendamustine and a rituximab product to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.

FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

Fri, 2019-06-07 15:46
FDA permits marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS.

Remarks on World Food Safety Day: ‘Food Safety Is Everyone’s Business’

Fri, 2019-06-07 15:46
Remarks from Deputy Commissioner Frank Yiannas on World Food Safety Day

FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf

Fri, 2019-06-07 12:46
FDA and FTC cite four firms that make or sell several flavored e-liquid products for violations related to online posts by social media influencers on each company’s behalf.

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

Wed, 2019-06-05 20:25
FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

Tue, 2019-06-04 17:18
FDA approves new use of Emgality to treat episodic cluster headache

Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law

Tue, 2019-06-04 08:17
Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law

FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia

Mon, 2019-06-03 17:13
FDA today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older.

Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine

Mon, 2019-06-03 14:13
Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine

FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer

Mon, 2019-06-03 08:13
The FDA Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer.

FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

Thu, 2019-05-30 16:53
FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids

Thu, 2019-05-30 10:51
FDA is soliciting feedback on the potential use of new authorities under the SUPPORT Act to require certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging.

FDA approves first PI3K inhibitor for breast cancer

Fri, 2019-05-24 16:24
FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant.

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