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.
CERTARA: FDA Renews Licenses for Synchrogenix’s GlobalSubmit Software to Review and Validate New Drug and Biologics Applications
Leveraged since 2005, 6,000+ FDA reviewers are now using GlobalSubmit technology
As more people become ill from using vaping products, government authorities are beginning to take a hard look at e-cigarettes.
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.
Draft guidance from the U.S. Food and Drug Administration (FDA) on real-world data (RWD) and real-world evidence (RWE) was released in May to mixed reaction from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.
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
The U.S. Food and Drug Administration barred 485 shipments from entering the United States in August, according to FDA import records.
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.
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).
The FDA has issued new draft guidance for labeling of prescription medications that could be abused, with the goal of making the risks of dependence clearer for health care providers and for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.
Representative Jim Struzzi (R-IN) introduced two new bills that have the potential to regulate cannabidiol (CBD) and kratom sales in Pennsylvania.
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.
Company’s New Collagen-Enhanced Bone Graft Material Receives US FDA 510(k) Clearance and Enters Domestic Market
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.