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News & Events

FDA confirms elevated levels of belladonna in certain homeopathic teething products

5 hours 4 min ago
The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs

5 hours 4 min ago
Today, the U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

FDA warns company for putting consumers at risk with drug manufacturing data integrity violations

Tue, 2019-08-20 11:21
The FDA posted a warning letter for significant current good manufacturing practice violations, including data integrity issues.

Statement on new results demonstrating continued success of the agency’s youth smoking prevention efforts and significant public health cost savings

Tue, 2019-08-20 08:21
A new study in the American Journal of Preventive Medicine highlights the continued success and impact the FDA’s “The Real Cost” campaign has had on youth smoking initiation.

FDA approves new antibiotic to treat community-acquired bacterial pneumonia

Mon, 2019-08-19 14:16
The FDA approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.

FDA warns consumers about the dangerous and potentially life threatening side effects of Miracle Mineral Solution

Mon, 2019-08-19 14:16
The FDA is warning consumers not to purchase or drink Miracle Mineral Solution, a product sold online as a medical treatment due to a recent rise in reported health issues.

FDA approves new device to improve symptoms in patients with advanced heart failure

Fri, 2019-08-16 17:00
FDA approves new device to improve symptoms in patients with advanced heart failure

FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery

Fri, 2019-08-16 13:57
FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery.

FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis

Fri, 2019-08-16 10:56
FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis

FDA approves treatment for patients with rare bone marrow disorder

Fri, 2019-08-16 10:56
FDA approves treatment for adult patients with certain types of myelofibrosis.

FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

Thu, 2019-08-15 16:52
FDA approves third cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated

FDA proposes new required health warnings with color images for cigarette packages and advertisements to promote greater public understanding of negative health consequences of smoking

Thu, 2019-08-15 10:50
FDA has issued a proposed rule to require new health warnings on cigarette packages and in ads to promote greater public understanding of the negative health consequences of smoking.

FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs

Wed, 2019-08-14 13:45
FDA approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis of the lungs.

FDA warns consumers about the dangerous and potentially life threating side effects of Miracle Mineral Solution

Mon, 2019-08-12 13:28
The FDA is warning consumers not to purchase or drink Miracle Mineral Solution, a product sold online as a medical treatment due to a recent rise in reported health issues.

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

Fri, 2019-08-09 16:08
FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.

FDA notifies four companies to remove 44 flavored e-liquid and hookah tobacco products from the market for not having required marketing authorization

Thu, 2019-08-08 10:00
FDA has notified four firms that 44 flavored e-liquid and hookah tobacco products do not have the required marketing authorization, and thus cannot be legally sold in the U.S.

Statement on data accuracy issues with recently approved gene therapy

Tue, 2019-08-06 12:50
Statement by Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on data accuracy issues with recently approved gene therapy

FDA statement on court ruling related to compounded bulk drug substances and the agency’s ongoing efforts to implement its compounding authorities

Tue, 2019-08-06 12:50
A U.S. District Court judge in Washington, D.C. issued a decision that upheld FDA’s interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in drug compounding.

FDA approves first therapy for rare joint tumor

Fri, 2019-08-02 15:24
FDA approves first therapy for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT)

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

Fri, 2019-08-02 15:24
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

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