fda

FDA Reminds Facilities to Register or Renew their Food Facility Registration

The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2024.




fda

FDA Revokes Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food

The agency concluded that the intended use of BVO in food is no longer considered safe after the results of studies.




fda

FDA Investigating Salmonella Outbreak Involving Cucumbers

Bedner Growers, Inc., of Boynton Beach, Fla., and Thomas Produce Company, of Boca Raton, Fla., are the likely sources of this outbreak, however these growers do not account for all the illnesses in the outbreak.




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FDA Partners with Purdue University and Indiana Agricultural Stakeholders on Salmonella Study

This study is intended to help the FDA and the local growing community better understand the source of pathogens, their persistence, and how they transfer through the growing environment to help inform food safety practices.




fda

National Academy of Medicine and FDA Announce the 2018 Tobacco Regulatory Science Fellows

The National Academy of Medicine (NAM) along with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) have named the 2018-2019 class of FDA Tobacco Regulatory Science Fellows.




fda

Prescribers Should Restrict the Use of Non-FDA-Approved Compounded Bioidentical Hormones, Except for Specific Medical Circumstances

The use of compounded bioidentical hormone therapies (cBHTs) — an increasingly popular approach to relieve symptoms of menopause and male hypogonadism — should be limited to the small number of patients who cannot benefit from an FDA-approved hormone therapy product, says a new report from the National Academies of Sciences, Engineering, and Medicine.




fda

Lack of Equitable Representation in Clinical Trials Compounds Disparities in Health and Will Cost U.S. Hundreds of Billions of Dollars - Urgent Actions Needed by NIH, FDA, Others to Boost Representation

Lack of representation in research is compounding disparities in health outcomes, with serious consequences for underrepresented groups and the nation as a whole. Urgent actions are needed by NIH, FDA, and others to boost representation of racial and ethnic minority groups and other underrepresented populations in clinical trials and research.




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MGP Ingredients receives FDA approval of Fibersym RW and FiberRite RW as a dietary fiber source

MGP Ingredients, Inc. is pleased to announce the formal approval of its citizen petition requesting dietary fiber status under the new nutrition facts labeling regulations for its flagship brands of Fibersym RW and FiberRite RW.




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FDA grants citizen petition on acacia (gum arabic) as dietary fiber

The U.S. Food and Drug Administration (FDA) announced that it intends to propose that “Acacia (Gum Arabic),” also known as gum acacia, be included as part of the FDA's definition of dietary fiber.




fda

ABA responds to recent FDA efforts

The Food and Drug Administration (FDA) has been on a roll lately. Its regulatory agenda is so full that advocates went to court to force timelines on the multitude of food-safety regulations required by the Food Safety Modernization Act (FSMA). 




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FDA provides guidance on dietary fibers

At long last, FDA has provided guidance on many dietary fibers. To be clear, the FDA announcement covers about 70–75 percent of common dietary fibers in use today, so more work needs to be done.




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FDA: Some PFAS Used for Food Packaging No Longer Being Sold in United States

In 2020, the U.S. Food and Drug Administration obtained commitments from manufacturers to cease sales for food contact use of grease-proofing substances that contain certain types of PFAS.




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AHA: President’s proposal to eliminate FDA tobacco oversight risks public health

“We strongly oppose the administration’s proposal to create a separate government agency to oversee tobacco products. This unfortunately comes from an administration that has repeatedly placed the needs of the tobacco industry on equal footing with public health.




fda

Embattled Johnson & Johnson recalls some of its baby powder after the FDA finds asbestos

Tainted love: Johnson & Johnson recalled 33,000 bottles of baby powder after the Food and Drug Administration found asbestos in one container, The New York Times reports. The company, which once marketed its baby, body, and wellness products as being “for all you love,” has long denied that its talc-based products ever contained cancer-causing asbestos, but it faces more than 15,000 lawsuits from customers who say their products caused them to develop ovarian cancer or mesothelioma, a rare cancer linked to asbestos.




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Glint Pharmaceuticals Receives FDA IND Acceptance for Clinical Study for Phase 1/2 Clinical Trial of Antibiotic Drug-Releasing Contact Lens, ACL5

Investigation to initiate in Q2 2023




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Premier TMS of LA to Offer Neuronetics' FDA-Cleared Transcranial Magnetic Stimulation (TMS) Therapy for Adolescent Depression

FDA-cleared depression treatment is a non-invasive procedure that does not require sedation or drugs, and has minimal to no side effects.




fda

Semaglutide Becomes First FDA-Approved Weight Management Treatment Since 2014

The Federal Drug Administration (FDA) has approved semaglutide for chronic weight management among overweight or obese adults. Semaglutide marks the first weight management treatment approved by the FDA since 2014.




fda

In victory for public health, federal appeals court upholds FDA’s graphic cigarette warnings

WASHINGTON, D.C. – In a major victory for public health, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit has unanimously upheld graphic  health warnings on cigarette packs and advertising required under a 2020 FDA rule. This...




fda

One year following court-ordered deadline, FDA must rule on remaining premarket tobacco applications

DALLAS, September 9, 2022 — Following is a statement from the American Heart Association, the world’s leading voluntary organization focused on heart and brain health: “One year after a court-ordered deadline to determine whether flavored e-cigarette ...




fda

Aptar Earns Acceptance to FDA's Emerging Technology Program for N-Sorb Solution

N-Sorb leverages Aptar CSP Technologies’ proven 3-Phase Activ-Polymer™ platform technology to address the pressing issue of N-nitrosamine impurities in pharmaceuticals.




fda

3D Printing Trade Association And The FDA Working Together

The FDA continues to take creative and flexible approaches to address access to critical medical products in response to COVID-19. Researchers at academic institutions, non-traditional manufacturers, communities of makers, and individuals are banding together to support and fill local and




fda

3D Printing And Covid 19 – What Is The FDA Doing?

The FDA continues to take creative and flexible approaches to address access to critical medical products in response to COVID-19. Researchers at academic institutions, non-traditional manufacturers, communities of makers, and individuals are banding together to support and fill local and




fda

FDA discourages use of laparoscopic power morcellation for hysterectomies

Dr. Jessica Shepherd, Assistant Professor of Clinical Obstetrics and Gynecology at the University of Illinois College of Medicine explains why the FDA discourages use of a laparoscopic surgery for hysterectomies and removal of uterine fibroids.




fda

FDA weighs in on testosterone benefits

Dr. Nachum Katlowitz, Director of Urology and Male Infertility at Staten Island University Hospital, discusses testosterone therapy and who are the best candidates for treatment.




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FDA rejects MDMA-assisted therapy for PTSD treatment

A growing body of evidence points to MDMA’s therapeutic potential for managing an array of hard-to-treat conditions like PTSD and depression.




fda

velocityconf: Call for speakers and registration is open for @webperfdays in Silicon Valley http://t.co/cJKBmynkjI June 22, Google HQ (cc @sfwebperf)

velocityconf: Call for speakers and registration is open for @webperfdays in Silicon Valley http://t.co/cJKBmynkjI June 22, Google HQ (cc @sfwebperf)




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Cancer drugs remain FDA approved despite lack of benefit, study finds




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US food manufacturer can say that eating yogurt reduces risk of type 2 diabetes, says FDA




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FDA approves first over-the-counter blood glucose monitor for diabetes




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FDA says commonly used decongestant 'not effective,' proposes removal

The U.S. Food and Drug Administration has determined commonly used oral phenylephrine is "not effective" and has proposed its removal from over-the-counter nasal decongestants.




fda

FDA says commonly used decongestant 'not effective,' proposes removal

The U.S. Food and Drug Administration has determined commonly used oral phenylephrine is "not effective" and has proposed its removal from over-the-counter nasal decongestants.




fda

Unified Design Strategy Addresses FDA Medical Device Regulations

SOLIDWORKS Helps Companies Automate Documentation, Analysis, and Data Management for Compliance




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FDA Bans Use of Shock Therapy at School for Students With Special Needs

The FDA estimates that between 45 and 50 students at a Massachusetts school for students with autism, emotional disturbances, and intellectual disabilities are subjected to electrical shocks through electrodes attached to their skin.




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FDA Authorizes Bivalent COVID-19 Boosters; CDC Sign-Off Expected By Weekend

DOVER, DE (August 31, 2022) – On Aug. 31, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to Pfizer and Moderna for their new bivalent boosters, meaning vaccine could start shipping to states that pre-ordered as early as Friday.  The Centers for Disease Control and Prevention’s (CDC) advisory committee meets Thursday and Friday, Sept. 1 and 2, […]




fda

Egg Recall: FDA Finds Salmonella on Suspect Farms

Title: Egg Recall: FDA Finds Salmonella on Suspect Farms
Category: Health News
Created: 8/27/2010 9:58:00 AM
Last Editorial Review: 8/27/2010 9:58:01 AM




fda

FDA Warns of Celexa Heart Risk

Title: FDA Warns of Celexa Heart Risk
Category: Health News
Created: 8/25/2011 11:01:00 AM
Last Editorial Review: 8/25/2011 12:00:00 AM




fda

FDA Approves New Once-a-Day HIV Pill

Title: FDA Approves New Once-a-Day HIV Pill
Category: Health News
Created: 8/28/2012 12:05:00 AM
Last Editorial Review: 8/28/2012 12:00:00 AM




fda

FDA Approves 1st Topical Gel to Ease Redness of Rosacea

Title: FDA Approves 1st Topical Gel to Ease Redness of Rosacea
Category: Health News
Created: 8/27/2013 12:35:00 PM
Last Editorial Review: 8/28/2013 12:00:00 AM




fda

FDA Approves New DVT Blood Clot Treatment

Title: FDA Approves New DVT Blood Clot Treatment
Category: Health News
Created: 8/23/2014 11:00:00 AM
Last Editorial Review: 8/25/2014 12:00:00 AM




fda

Steer Clear of Dietary Supplements for Concussions: FDA

Title: Steer Clear of Dietary Supplements for Concussions: FDA
Category: Health News
Created: 8/26/2014 12:35:00 PM
Last Editorial Review: 8/27/2014 12:00:00 AM




fda

FDA Approves Second Drug in New Class of Cholesterol-Lowering Medications

Title: FDA Approves Second Drug in New Class of Cholesterol-Lowering Medications
Category: Health News
Created: 8/28/2015 12:00:00 AM
Last Editorial Review: 8/28/2015 12:00:00 AM




fda

Use of Cancer-Linked Fibroid Device Declines After FDA Warning

Title: Use of Cancer-Linked Fibroid Device Declines After FDA Warning
Category: Health News
Created: 8/23/2016 12:00:00 AM
Last Editorial Review: 8/24/2016 12:00:00 AM




fda

FDA OKs New Antibacterial Drug

Title: FDA OKs New Antibacterial Drug
Category: Health News
Created: 8/31/2017 12:00:00 AM
Last Editorial Review: 8/31/2017 12:00:00 AM




fda

Warning Letters Target Illegal Online Sales of Opioid Meds: FDA

Title: Warning Letters Target Illegal Online Sales of Opioid Meds: FDA
Category: Health News
Created: 8/28/2018 12:00:00 AM
Last Editorial Review: 8/29/2018 12:00:00 AM




fda

FDA Warns of Serious Genital Infection With Diabetes Meds

Title: FDA Warns of Serious Genital Infection With Diabetes Meds
Category: Health News
Created: 8/30/2018 12:00:00 AM
Last Editorial Review: 8/30/2018 12:00:00 AM




fda

Men Should be Included in Breast Cancer Clinical Trials: FDA

Title: Men Should be Included in Breast Cancer Clinical Trials: FDA
Category: Health News
Created: 8/26/2019 12:00:00 AM
Last Editorial Review: 8/27/2019 12:00:00 AM




fda

FDA Warns of Liver Problems for Some Taking Hep C Drugs

Title: FDA Warns of Liver Problems for Some Taking Hep C Drugs
Category: Health News
Created: 8/29/2019 12:00:00 AM
Last Editorial Review: 8/29/2019 12:00:00 AM




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FDA Approves Wider Use of Plasma as Coronavirus Treatment

Title: FDA Approves Wider Use of Plasma as Coronavirus Treatment
Category: Health News
Created: 8/24/2020 12:00:00 AM
Last Editorial Review: 8/25/2020 12:00:00 AM




fda

FDA Approves New Rapid Coronavirus Test

Title: FDA Approves New Rapid Coronavirus Test
Category: Health News
Created: 8/27/2020 12:00:00 AM
Last Editorial Review: 8/27/2020 12:00:00 AM




fda

Rapid 15-Minute COVID-19 Test Approved By FDA

Title: Rapid 15-Minute COVID-19 Test Approved By FDA
Category: Health News
Created: 8/27/2020 12:00:00 AM
Last Editorial Review: 8/28/2020 12:00:00 AM