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A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes

FDA Law

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. They argued that the legislation was necessary to spur innovation of new vaccines and therapies in response to emerging health threats.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. We will continue to monitor these developments as they come.

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CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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A Review of H5N1

Alabama Academy of Family Physicians

By Wes Stubblefield, MD, MPH, FAAP ADPH Medical Officer H5N1 influenza, or “bird flu,” is a type of influenza that was first discovered in the 1950s. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. For the public, cautious monitoring is recommended.

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Arsenicum album for Kerala school students: a bogus prophylaxis

Tiny Physician

On the brighter side, daily case count drastically decreased and vaccination drive is happening at top speed. Almost 1 billion doses of vaccine have been administered so far and the situation is currently under control. However, there is no clinical trial on its effect on COVID 19 infection or its complications.