Tuesday, February 18, 2020

Tuesday, February 18, 2020

U.S. Food and Drug Administration (FDA) News

FDA vaping regulations will hurt consumers, independents, CASAA says

As FDA deadlines approach for regulations on electronic tobacco products, observers say the industry is in for a period of change and consolidation.

FDA issued 13 warning letters in October

The U.S. Food and Drug Administration (FDA) issued 13 warning letters in October that were sent to manufacturers and other companies found to have violated FDA regulations.

FDA reports progress in support of opioid recovery and treatment act

The U.S. Food and Drug Administration's (FDA) acting commissioner, Dr. Ned Sharpless, has released a statement on the agency’s efforts to address the opioid crisis as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act marked its one year anniversary on Oct. 24.

Sterilization facility closures may threaten availability of medical devices, FDA cautions

Acting commissioner of the U.S. Food and Drug Administration (FDA) Dr. Ned Sharpless recently released a statement regarding medical device availability following the closure of multiple sterilization facilities.

FDA approved record number of generic drugs in 2018

A new report on the U.S. Food and Drug Administration's (FDA) generic drug program highlights the agency's all-time record number of approvals for fiscal year 2018.

FDA Update: 2019 animal product recalls

The U.S. Food and Drug Administration recalled 28 animal products from January through September of 2019, the agency reported.

FDA Update: recent animal drug approvals

Federal law dictates that drug companies can’t manufacture and market medicines for animals unless they get the approval of the U.S. Food and Drug Administration.

FDA awards $15 million grant to 12 new clinical trials for rare-disease treatments

Over the next four years, the U.S. Food and Drug Administration (FDA) will be providing more than $15 million to 12 new clinical trials. The grants will help enhance the development of medical products for patients with rare diseases – mainly those affecting children.

FDA awards more than $4.1 million for natural history studies of rare diseases

The U.S. Food and Drug Administration (FDA) is providing more than $4.1 million in the next four years to fund two natural history studies of rare diseases.

FDA issued 19 warning letters to companies in September

The U.S. Food and Drug Administration issued 19 warning letters in September that were sent to manufacturers and other companies found to have violated FDA regulations.

FDA issues Salmonella, Listeria warnings for Performance Dog frozen raw pet food

A Performance Dog frozen raw pet food sample has tested positive for Salmonella and Listeria monocytogenes (L. mono), causing the U.S. Food and Drug Administration (FDA) to issue a warning to pet owners.

Acting FDA commissioner addresses vaping illnesses before the U.S. House Energy and Commerce Subcommittee

Acting Commissioner of the U.S. Food and Drug Administration (FDA) Norman E. ("Ned") Sharpless, M.D., has presented his remarks on the FDA’s planned regulation of electronic nicotine delivery systems (ENDS), including the investigation of vaping illnesses, before the U.S. House Energy and Commerce Subcommittee.

FDA proposes new rule for premarket tobacco product applications

Premarket tobacco product applications (PMTAs) now have new requirements for the content, format and Food and Drug Administration (FDA) review and communication procedures after the FDA issued a proposed rule in their efforts to lessen the number of e-cigarette and other tobacco products on the market.

FDA working to increase availability of Naloxone

The opioid crisis has become such a public health crisis that there is now a Prescription Opioid and Heroin Epidemic Awareness Week to focus on the dangers of opioid addiction as well as treatment options treatment – which includes access to Naloxone.

FDA Update: international cooperative arrangements

Since the year 2000, the U.S. Food and Drug Administration has entered into 40 cooperative arrangements involving foods, pharmaceuticals or medical devices with foreign governments or partners in other nations, according to the FDA.

FDA Update: Import refusals in August

The U.S. Food and Drug Administration barred 485 shipments from entering the United States in August, according to FDA import records.

Trump administration's flavored vaping ban doesn't go far enough, bipartisan group says

The Trump administration’s move to ban certain flavors of e-cigarettes and vaping devices either goes too far or doesn’t go far enough, according to those on opposite sides of the debate.

Research and Markets holds seminar on medical device obstacles

ResearchAndMarkets.com held a seminar in San Diego on Sept. 12 and 13 entitled, "Managing Your Complaints and Obstacles in Post-Market Requirements – Results from Top Medical Device Observations During an Inspection.”

LifeKit Prevent Test earns Breakthrough Device designation from FDA

The Food and Drug Administration (FDA) has granted a submission for a Breakthrough Device designation from Prescient Metabiomics for its LifeKit Prevent Colorectal Neoplasia Test for the early detection of colon polyps and colon cancer.

FDA creating new labeling guidelines for opioid medications

The FDA has issued new draft guidance for labeling of prescription medications that could be abused, with the goal of making the risks of dependence clearer for health care providers and for patients.

FDA Reporter