Agency IQ

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended. Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 17, 2024

And even if not, the doctor must participate in the medical treatment that facilitates an abortion. The Doctors allege that being made to provide this treatment conflicts with their sincerely held moral beliefs and violates their rights of conscience. The Supreme Court today provided a unanimous rebuke to this theory of standing.

FDA 40

FDA Doctors Testimonials Regulations 40

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. The final rule will amend the administrative destruction provisions in 21 CFR 1.94 to include devices.

FDA 40

FDA Science Regulations Production 40

Drug & Device Law

JANUARY 19, 2024

at *2 (we’ve previously posted that such testimony is insufficient to establish causation ). The Court had none of it: Even assuming that the failure to describe the learning curve is not a preempted attack on FDA-approved information., The implanter had attended training with the manufacturer to learn the implant procedure.

Testimonials 52

Testimonials FDA Approval Production FDA 52

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.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

DECEMBER 21, 2023

Shikada is the first appellate decision creating a state-law warning-based duty (here, via a consumer protection claim, brought by the state rather than anyone actually claiming injury) based solely on pharmacogenomics − racially/ethnically-based genetic variations − allegedly affecting the effectiveness of FDA-approved prescription drugs.

FDA Approval 52

FDA Approval FDA Drugs Production 52