FDA Law Blog: Biosimilars

MARCH 24, 2025

In January a public hearing began to receive factual evidence and testimony on whether marijuana should be rescheduled. Marijuana down-rescheduled to schedule III would still be regulated for legitimate medical, scientific and industrial use. The hearing is currently on hold pending an appeal by several of the parties.

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Regulations Testimonials Licensing Licensing 71

FDA Law Blog: Biosimilars

APRIL 22, 2025

If you decide to request a hearing, DEAs revised hearing regulations require that you simultaneously file an Answer to the Order to Show Cause. Both the government (represented by DEA counsel) and you will have an opportunity to present your case through witness testimony and record evidence.

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Testimonials Government Pharmacy Regulations 52

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

Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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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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Government FDA Biosimilars Regulations 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Production 40

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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Nurses FDA Testimonials Doctors 59