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FDA Launches Portal for Submission of Orphan Drug Designation Requests

FDA Principal Deputy Commissioner Amy Abernethy M.D., Ph.D. "Developing a treatment for a rare disease can be complex. Collaboration, including through the use of technology, is critical to supporting and facilitating efficient processes for these types of necessary treatments.

Emergency Use Authorizations: FDA’s Ongoing Commitment to Transparency for COVID-19

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D

Medicrea International Acquisition Completed

This is Medtronic's seventh acquisition completed in 2020 and furthers Medtronic's strategic expansion into AI, machine learning, and predictive analytics.

COVID-19 Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

Although the FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but do not necessarily decrease the infection and destruction of cells.

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 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.