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☆ U.S. FDA calls for new regulatory framework for use of cannabis compound CBD
▼ + stars: | 2023-01-26 | by ( ) www.reuters.com time to read: +2 min

The first-ever cannabis farmer's market in Los Angeles began on July 4 and opens weekly from Friday to Sunday. The health regulator said it would work with Congress to develop a new, cross-agency regulatory framework. The FDA has generally pursued limited enforcement activity regarding CBD, focusing primarily on food and beverage products that make unsubstantiated health claims. "A new regulatory pathway for CBD is needed that balances individuals' desire for access to CBD products with the regulatory oversight needed to manage risks," the agency said. Cannabis products, excluding Jazz Pharmaceuticals Plc's (JAZZ.O) epilepsy drug Epidiolex, are illegal at the federal level in the United States, although some states allow their use.

☆ We read through the 45-page congressional investigation into Biogen's Alzheimer's drug. Here are the 3 most shocking takeaways.
▼ + stars: | 2022-12-29 | by ( Yeji Jesse Lee | Leah Rosenbaum | ) www.businessinsider.com time to read: +8 min

A Congressional investigation into Biogen's controversial Alzheimer's drug Aduhlem was just released. Aduhelm was developed by Cambridge, Massachusetts-based biotech company Biogen and Japanese pharmaceutical company Eisai. The duo is currently developing another Alzheimer's drug, called lecanemab, which is expected to receive approval from the FDA in January and has shown more promising data in clinical trials. Insider reviewed the 45-page investigation into Biogen's Alzheimer's drug. Here are three of the most shocking takeaways:Biogen gave Aduhelm a crazy price tag despite knowing it would become inaccessible to many patientsFrom the moment Biogen announced Aduhelm's $56,000 price tag, the company faced backlash.

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☆ FDA, Concerned About Safety, Explores Regulating CBD in Foods, Supplements
▼ + stars: | 2022-12-27 | by ( Liz Essley Whyte | ) www.wsj.com time to read: 1 min

The Food and Drug Administration is studying whether legal cannabis is safe in food or supplements and plans to make recommendations for how to regulate the growing number of cannabis-derived products in the coming months, agency officials said. “Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” said FDA Principal Deputy Commissioner Janet Woodcock , who has led the agency’s efforts looking at cannabis regulation.

☆ Vaccinul Pfizer a fost autorizat în SUA copiilor cu vârsta peste 12 ani
▼ + stars: | 2021-05-11 | by ( Publika.Md - Aici Sunt Știrile | ) www.publika.md time to read: +1 min

Autorizarea vaccinului împotriva COVID-19 produs de Pfizer/BioNTech a fost extinsă la adolescenţii cu vârste cuprinse între 12 şi 15 ani în Statele Unite. „Părinţii şi tutorii pot fi siguri că Agenţia a efectuat o analiză riguroasă şi detaliată a tuturor datelor disponibile”, a spus Woodcock. Canada a devenit miercuri prima ţară care a autorizat vaccinul pentru această grupă de vârstă. „Vom fi gata să acţionăm imediat”, a spus el. În prezent sunt autorizate alte două vaccinuri în Statele Unite, cele de la Moderna şi Johnson & Johnson, ambele cu începere de la 18 ani.

Persons: Statele Unite ., Janet Woodcock, Agenţia, american Joe Biden, Johnson Organizations: Agerpres, Albă, Johnson Locations: Statele Unite, Canada, SUA

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