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Preview: Food and Drug Administration--Press Releases

Food and Drug Administration--Press Releases



Press releases from FDA



Last Build Date: Tue, 16 Jan 2018 14:36:00 -0500

 



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

Tue, 16 Jan 2018 14:36:00 -0500

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



Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs

Tue, 16 Jan 2018 14:20:00 -0500

GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.



FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids

Tue, 16 Jan 2018 13:11:00 -0500

FDA updates on some ongoing shortages related to IV fluids



FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel

Tue, 16 Jan 2018 10:06:00 -0500

The U.S. Food and Drug Administration and the Department of Defense launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.



FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs

Tue, 16 Jan 2018 08:34:00 -0500

FDA takes steps to enhance transparency of clinical trial data used in support of new drug approvals



Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products

Fri, 12 Jan 2018 10:20:00 -0500

: FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products



FDA approves first treatment for breast cancer with a certain inherited genetic mutation

Fri, 12 Jan 2018 09:37:00 -0500

FDA approves first treatment for breast cancer with a certain inherited genetic mutation



FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues

Thu, 11 Jan 2018 14:38:00 -0500

FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues



FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use

Thu, 11 Jan 2018 12:18:00 -0500

The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.



Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages

Thu, 04 Jan 2018 14:30:00 -0500

Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages



Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance

Thu, 04 Jan 2018 12:49:00 -0500

FDA announced today guidance outlining four key areas that it does not intend to enforce in the FDA Food Safety Modernization Act rules. The provisions relate to the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food.



FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell

Thu, 04 Jan 2018 11:44:00 -0500

FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product



Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices

Wed, 03 Jan 2018 10:48:00 -0500

FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. FDA is releasing two documents that together will improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs).



FDA permits marketing of device to treat diabetic foot ulcers

Thu, 28 Dec 2017 14:59:00 -0500

FDA permits marketing of device to treat diabetic foot ulcers



Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls

Tue, 26 Dec 2017 09:17:00 -0500

FDA discusses the steps taken to improve the recall process, the HHS OIG report on recalls, and new policies being considered.



FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

Fri, 22 Dec 2017 16:03:00 -0500

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response



FDA clears stereotactic radiotherapy system for use in treating breast cancer

Fri, 22 Dec 2017 10:11:00 -0500

FDA clears stereotactic radiotherapy system for use in treating breast cancer



FDA approves drug to treat dangerously low blood pressure

Thu, 21 Dec 2017 17:54:00 -0500

The FDA today approved the new drug Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock.



FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss

Tue, 19 Dec 2017 10:32:00 -0500

FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss



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

Mon, 18 Dec 2017 11:25:00 -0500

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.