Agency IQ

JUNE 17, 2024

As reported by POLITICO , “The decision — if allowed by the Supreme Court to take effect — would roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs.

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FDA Doctors Testimonials Regulations 40

Agency IQ

SEPTEMBER 29, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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FDA Science Regulations Production 40

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. They excluded bogus expert testimony under Fed. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir.

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Testimonials FDA Drugs Vaccine 105

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. 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