Manufacturing Patients Provider Vaccination 
Alabama Academy of Family Physicians
FEBRUARY 19, 2025
HB 2 – Vaccine Consent What’s in the Bill: Sponsored by Rep. Under current law, minors aged 14 or older are permitted to consent to vaccines (excluding the Covid Vaccine) for themselves without parental consent. Senate SB 43 – Patient Price Transparency Bill What’s in the Bill: Sponsored by Sen.
FDA Law Blog
SEPTEMBER 30, 2024
CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.
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FDA Law Blog
OCTOBER 24, 2024
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.
FDA Law Blog
JUNE 2, 2023
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.
FDA Law Blog
JANUARY 3, 2024
Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).
FDA Law Blog
AUGUST 21, 2023
After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. Just like it was over a decade ago in Pliva v. FDA, for years, has been concerned with overwarning.
Alabama Academy of Family Physicians
FEBRUARY 20, 2025
Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. For providers, it is highly encouraged to submit samples from hospitalized patients to a laboratory capable of identifying H5N1 if influenza is confirmed in the inpatient setting and H5N1 is suspected.
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