Sunday, October 20, 2019

Sunday, October 20, 2019

Latest News

FDA unveils guidances for digital health care

The U.S. Food and Drug Administration (FDA) recently unveiled a series of guidances about utilizing digital health tools to help patients.

Pressure mounts on politicians, FDA to react to vaping-related illnesses, deaths

According to an article on the Forbes website, vaping will impact two sectors of the financial markets the most: Big Tobacco and marijuana stocks.

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.

U.S. FDA: Statement on continued efforts to evaluate materials in medical devices to address potential safety questions

Statement from Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health on continued efforts to evaluate materials in medical devices to address potential safety questions

ENDO INTERNATIONAL: Announces Successful Culmination of Litigation Regarding FDA Compounding Policy

Endo International plc ("Endo") (NASDAQ: ENDP) today announced the successful culmination of two litigation matters before the U.S. District Court for the District of Columbia regarding the unlawful compounding of vasopressin from bulk drug substances.

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.

Vaping illnesses caused by illegal substances, AVA says

As more people become ill from using vaping products, government authorities are beginning to take a hard look at e-cigarettes.

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 draft guidance elicits mixed reactions

Draft guidance from the U.S. Food and Drug Administration (FDA) on real-world data (RWD) and real-world evidence (RWE) was released in May to mixed reaction from stakeholders.

Myths influencing FDA and CDC vaping policies, ACSH says

The U.S. Food and Drug Administration (FDA) and the U.S. Center for Disease Control (CDC) are relying on myths to scare people away from vaping, according to Alex Berezow of the American Council on Science and Health (ACSH).

U.S. FDA: Statement from Acting FDA Commissioner Ned Sharpless, M.D., on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths

Addressing opioid overdose continues to be one of the most urgent public health priorities for the U.S. government and making potentially lifesaving treatments more readily available is one of the top ways we can address this crisis

FDA Reporter