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.

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Insurance Management Hospital Vaccination 130

FDA Law

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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Manufacturing Utilities Provider IT 59

FDA Law

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. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however. animal, viral, bacterial) DNA and RNA sequences.

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FDA Law

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.

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Manufacturing Vaccination Government Diagnosis 59

FDA Law

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). The unapproved drug claims are not, in and of themselves, notable, but it is always interesting when FDA takes a stand against such a large swath of manufacturers and distributors at the same time.

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Manufacturing Education Patient-Centered Vaccination 59

FDA Law

MAY 15, 2025

Stage IV cancer should not be approved like a cosmetic, he quipped, quickly calling to mind his days as an oncological surgeon and the many difficult conversations he had with patients and families with very limited options. The agency, he noted, isnt a passive inbox for industry petitions.

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Manufacturing Illness Vaccination IT 59

FDA Law

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. Koblitz & Deborah L. More than a few have taken far longer—literally decades.

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