#regulatory-guidance
#regulatory-guidance

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FDA Wants to Make Life Easier for Biosimilars

FDA draft guidance relaxes biosimilar testing requirements, allowing analytic and targeted human studies in place of comparative efficacy trials to speed cheaper biosimilars.

fromNature

3 months ago

Weaponizing uncertainty in science and in public health puts people in harm's way

On 22 September, the United States' top public-health officials stood alongside President Donald Trump at the White House and delivered a message that went around the world in an instant. The US Food and Drug Administration (FDA) said it intends to change its guidance on acetaminophen - also known as paracetamol - a household painkiller marketed in the United States as Tylenol.

Public health

fromFortune Crypto

6 months ago

The SEC opened the 'floodgates' for crypto ETFs, experts say, marking a new era for the industry

The guidance comes under the commission's new chairman, Paul Atkins, a Trump appointee who is a contrast with previous leadership that sought to block the approval of Bitcoin ETFs.

Cryptocurrency

fromcointelegraph.com

7 months ago

How to legally stake crypto in 2025: What is now allowed after the SEC's latest move

The SEC clarified that certain types of crypto staking do not qualify as securities offerings, fostering regulatory certainty for stakers.

Cryptocurrency

fromBitcoin Magazine

8 months ago

OCC Gives Banks The Green Light To Offer Bitcoin And Crypto Custody And Trading Services

OCC allows national banks to provide crypto custody and trading services, emphasizing risk management.