FDA Law Blog: Biosimilars

DECEMBER 12, 2024

The purpose of the public hearing is to receive factual evidence and expert opinion testimony on whether marijuana should be rescheduled to schedule III. Parties will have ninety minutes to present the testimony of their witness. Prehearing Ruling (Dec. 4, 2024), at 1.

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Testimonials Regulations Drugs 52

Conversations in Drug Development Trends

OCTOBER 29, 2024

Through relationship-building and increased engagement, regulators aim to improve their understanding of the ‘lived experience’ of patients with rare diseases and hear their top concerns. Discover more about this industry shift in our blog.

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Clinical Research Disease Research Clinical Trials 72

Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

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FDA Law Blog: Biosimilars

JULY 21, 2024

FDA — were a group of environmentally conscious interest groups that brought suit against FDA to better regulate the use some antimicrobials in livestock and poultry. In alleging that antibiotic use was a public health problem that FDA should regulate, the plaintiffs offered several testimonials from ostensibly affected people.

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FDA Law Blog: Biosimilars

MARCH 14, 2023

Merrick Garland, Testimony Before the Senate Judiciary Committee, Mar. AG Garland opined during his confirmation that he did not think it the best use of DOJ’s limited resources to prosecute those who are complying with the laws in those states that have legalized marijuana and are effectively regulating it. 1, 2023 ( 02:38:46 ).

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Drug & Device Law

FEBRUARY 16, 2024

The Dearinger case in the Western District of Washington provided a lot of defense friendly blog fodder. We blogged about that decision here. Plaintiffs provided testimony from that physician suggesting that he would have changed his prescribing decision if presented with plaintiffs’ proposed warning language.

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Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. 22 (both articles for the proposition that there are “‘many intense side effects’ and ‘significant complications requiring medical attention’” resulting” from FDA’s regulation of mifepristone), at *22 n.37 We were hardly alone.

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