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Schedule III Marijuana Would Still Be Regulated Marijuana

FDA Law Blog: Biosimilars

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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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Conversations in Drug Development Trends

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. For example, Voice of the Patient and Patient-Focused Drug Development meetings are focused on one disease or a group of similar diseases.

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New FDA guidance on addressing misinformation under White House review

Agency IQ

BY LAURA DIANGELO, MPH A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA). Fill out the form to read the full article.

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Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules

FDA Law Blog: Biosimilars

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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Bogus ‘Cure’ Claims Have U.S. Consumers Snapping Up CBD Products

The Pharma Data

A random sample of 376 posts labeled testimonials found that 90% cited using CBD to treat diagnosable medical conditions. Nearly two-thirds of the testimonials discussed its use for treating mental or emotional problems. Nearly two-thirds of the testimonials discussed its use for treating mental or emotional problems.

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Analysis Chemical Thank You Freedhoff testifies in front of Senate EPW over TSCA implementation

Agency IQ

SHELLEY MOORE CAPITO (R-WV) opened the testimony. Carper noted that the issues with how the EPA has implemented TSCA has led to “grievances” from both the chemical industry and environmental advocates, as the flow of chemicals to market and regulation of harmful chemicals has slowed. Opening Sen. TOM CARPER (D-DE) and Sen.

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What To Do When You Receive a DEA Order to Show Cause

FDA Law Blog: Biosimilars

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.