Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

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Drug & Device Law

FEBRUARY 20, 2023

For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims. Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v.

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FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 4, 2024

The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. 2003); Birdsong v. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” FDA (8/23/21) press release (emphasis original). 523, 529 (S.D.

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Vaccine FDA FDA Approval Pharmacy 59