The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. Elsewhere around the world: Avacta Group – U.K.-based Shanghai Haini Pharmaceutical — China’s Shanghai Haini Pharmaceutical Co., million seed funding round.

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Agency IQ

SEPTEMBER 1, 2023

“FDA does not consider these types of studies to be clinical investigations under part 312, and an IND is not required,” the guidance explains. However, sponsors will still need to ensure the protection of the subjects in their study, including through compliance with 21 CFR parts 50 and 56.

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FDA Science Regulations Production 40

The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. “With the acquisition of this intellectual property, we have solved the problem that has plagued psychedelic therapies for so many decades.

Bioethics 40

Bioethics Clinical Research Regulations Clinical Trials 40

Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 2, 2024

What When it might happen Additional details FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Clinical Trials Regulations 40

Agency IQ

MAY 28, 2024

Companies are paying for performance here, and it’s reasonable for them to expect performance” remarked Burgess, “And then we hear other discussions that the FDA wants to vastly expand its authority into licensing laboratory developed tests. If you don’t have the staff to do this, how are you going to have the staff to do that?”

FDA 40

FDA Production Science Clinical Trials 40

Drug & Device Law

JULY 31, 2023

However, licensed software can be a UCC sale of “goods.” Rather, Lowe relied on broadly applicable negligence principles involving consumer expectation and compliance with industry standards, as it would for any run-of-the-mill tangible product. 2021) (citation omitted). citation and quotation marks omitted). 1536, 1542 (N.D.

Production 52

Production International Trials Government 52