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Latest Biotechnology, Pharmaceutical and Healthcare News from FDA

15:28 EST 21st February 2019 | BioPortfolio

Here are the most relevant search results for "FDA" found in our extensive news archives from over 250 global news sources.

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Showing News Articles 1–25 of 730 from FDA

Thursday 21st February 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes

FDA releases the second of two draft guidances aimed at supporting the development of novel nicotine replacement therapies.

FDA advances new proposed regulation to make sure that sunscreens are safe and effective

FDA issues a proposed rule that would update regulatory requirements for most sunscreen products in the United States

Tuesday 19th February 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatmen

FDA statement cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions

Friday 15th February 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

FDA announces new draft guidance titled, Competitive Generic Therapies, to help provide even greater clarity to industry about the CGT pathway.

Thursday 14th February 2019

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

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

FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

Wednesday 13th February 2019

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas on findings from the agency’s investigation of the November 2018 outbreak of E. coli O157:H7 in California-linked romaine lettuce

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas on findings from the agency’s investigation of the November 2018 outbreak of E. coli O157:H7 in California-linked romaine lettuce

Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

FDA announces programs to promote adoption of innovations in drug manufacturing

Tuesday 12th February 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.

Monday 11th February 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use

Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use.

FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

FDA announces new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

Watch Out for False Promises About So-Called Alzheimer’s Cures

Unfortunately, when faced with a serious health issue, even the most rational person can be led to believe implausible claims.

Thursday 7th February 2019

FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines

FDA announces pilot program to improve ability to trace prescription drugs at all points in the drug distribution chain.

FDA pursues order barring specific retailers from selling tobacco products as part of its continuing efforts to target youth tobacco use

FDA has initiated enforcement action against certain retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls

Wednesday 6th February 2019

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants

Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions

Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions

FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder

FDA approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.

Tuesday 5th February 2019

March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

Friday 1st February 2019

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

Medical product distributor issued voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter devices.

Thursday 31st January 2019

February 12, 2019: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee

February 12, 2019: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee

Wednesday 30th January 2019

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee

February 12, 2019: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines

FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines

FDA approves first generic Advair Diskus

FDA approved the first generic of Advair Diskus for treatment of asthma and maintenance treatment of airflow obstruction and reducing exacerbations with COPD.


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