Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc. The content will include both goals for enrollment of populations and rationales for those goals.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. The rule, will also, if finalized, address communication with State boards of pharmacy. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

Regulations 40

Regulations FDA Science Production 40

Drug & Device Law

DECEMBER 29, 2023

Infectious Diseases Society of America , 86 F.4th 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. They had no expert testimony supporting causation, so the defendant won summary judgment. 4th 315 (6th Cir.

Testimonials 105

Testimonials FDA Drugs Vaccine 105