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Protecting Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance: FDA Takes Efforts

November 6, 2020 Protecting patients from exposure to poor quality compounded drugs is a fundamental part of the U.S. Food and Drug Administration's drug compounding program, and we are committed to protecting patients. While compounded drugs can serve an...

U.S. Food and Drug Administration Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order

A recent executive order directed the agency, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures, and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.

U.S. Food and Drug Administration Approves Lotion for Nonprescription Use to Treat Head Lice

The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.

Using NSAIDS, Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications Reports FDA

NSAIDs include medicines such as ibuprofen, naproxen, diclofenac, and celecoxib. People have taken these drugs for decades to treat pain and fever from many medical conditions. There are both prescription and over-the-counter.

Opiods: FDA Finalizes Guidance to Encourage Development of Novel Medicines to Treat Opioid Use Disorder

"As we combat the COVID-19 crisis, we are also focused on addressing the other health crises facing our country, including the ongoing substance use disorder and overdose crisis that our country is battling. Drug overdose deaths continue to rise in our country, and opioids, especially synthetic opioids, continue to be a driver of that trend.

FDA Achieves Key Milestone, Finalizes Framework That Will Resume Shellfish Trade with Europe for the First Time in 10 Years

The announcement today is a significant milestone that will resume trade in shellfish between the U.S. and the EU for the first time since 2010

FDA issues first injunction under Produce Safety Rule to Illinois-based Food Manufacturer for Repeated Food Safety Violations

FDA reports the action marks the first consent decree of permanent injunction against a firm or grower for violating public safety standards under the Produce Safety Rule enacted under the Food Safety Modernization Act of 2011.

U.S. Food and Drug Administration: National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products

FDA notes the findings come as we mark today’s premarket review submission deadline, a milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by the FDA.