Tuesday, February 25, 2020

Tuesday, February 25, 2020

Latest News

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FDA draft guidance elicits mixed reactions

Draft guidance from the U.S. Food and Drug Administration (FDA) on real-world data (RWD) and real-world evidence (RWE) was released in May to mixed reaction from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

FDA removes alcohol contraindication from Addyi

The U.S. Food and Drug Administration (FDA) removed the alcohol contraindication from Addyi, the only FDA-approved treatment for pre-menopausal women for Hypoactive Sexual Desire Disorder (HSDD).

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.

New legislation proposed to regulate Pennsylvania CBD and kratom sales

Representative Jim Struzzi (R-IN) introduced two new bills that have the potential to regulate cannabidiol (CBD) and kratom sales in Pennsylvania.

FDA held 10 drug application meetings in first 9 months of FY 2019

The U.S. Food and Drug Administration held 10 public meetings related to the review of license applications for drugs and biologics during the first three quarters of fiscal-year 2019, the regulatory agency reported last month.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on improving adverse event reporting of compounded drugs to protect patients

Compounded drugs can serve an important medical need for certain patients, however, they also present risksExternal Link Disclaimer to patients since they are not evaluated by the FDA for safety, effectiveness and quality.

BIOGENNIX: Launches Agilon Bone Grafting Solution

Company’s New Collagen-Enhanced Bone Graft Material Receives US FDA 510(k) Clearance and Enters Domestic Market

Applications for new drugs, biological products dip slightly in FY2019

New drug and biological product application filings were down slightly in the first three quarters of the current fiscal year, compared to the same period in the previous year, according to data released by the U.S. Food and Drug Administration.

U.S. FDA: Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations

A federal court has ordered two Tennessee-based companies and their owner to stop distributing drugs, dietary supplements and devices until the companies comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in a consent decree.

FDA Reporter