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. ALLIANCE FOR HIPPOCRATIC MEDICINE ET AL.

FDA 40

FDA Doctors Testimonials Regulations 40

Agency IQ

SEPTEMBER 29, 2023

That will have meant that FDA flagrantly missed its deadline to issue a guidance document related to medical countermeasure submissions and the use of Drug Master Files for platform technologies, which was due June 24, 2022. FDA is also due to revise 24 other guidance documents at that time.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. FDA is also due to revise 24 other guidance documents at that time. AgencyIQ November 18 Shutdown (?)

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The rule, will also, if finalized, address communication with State boards of pharmacy.

Regulations 40

Regulations FDA Science Production 40

Drug & Device Law

JULY 24, 2023

at *6 (plaintiff “has documents and formularies reaching back to only 2009”). the relationship between [plaintiff] and its pharmacy benefit manager. . . the relationship between [plaintiff] and its pharmacy benefit manager. . . First, the class plaintiff got away with destruction of evidence. 2023 WL 4191651, at *8.

Testimonials 52

Testimonials Pharmacy FDA Doctors 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. Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir. Monsanto Co. ,

Testimonials 105

Testimonials FDA Drugs Vaccine 105