Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA 40

FDA Production Regulations Vaccine 40

Codon

MARCH 24, 2024

Novo Nordisk’s market capitalization ($442B) is already larger than the GDP of Denmark ( $404B ), the country where the company is headquartered. The market for semaglutide-based products is projected to swell to $71B in less than a decade. market with Wegovy will, by 2030, require about one million liters of production capacity.

Engineering 85

Engineering Vaccine Production RNA 85

The Pharma Data

MARCH 31, 2023

Unitaid is working with implementing partners to ensure optimal use as part of a PrEP package that enables choice, and with the Coalition and other international partners to make long-acting PrEP options equitably accessible as quickly as possible.” Shionogi became a ViiV shareholder in October 2012. Access the sublicence agreements.

Licensing 40

Licensing Licensing International Treatment 40

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

FDA 40

FDA Science Biosimilars Regulations 40

Drug & Device Law

JULY 31, 2023

2012), computer code was not a “product” for purposes of the National Stolen Property Act, 18 U.S.C. no[r] a marketing product” under Lanham Act). 2012 WL 5932437 (N.D. 27, 2012), limited the undefined term “product” in an Alabama sales commission statute to tangible things, excluding franchise rights. at 1293-94.

Production 52

Production International Trials Government 52

Drug & Device Law

JUNE 6, 2022

2012), it had to apply the rule. 2012 WL 12848432, at *4 (E.D. 4, 2012) (no causation were, “[u]nderstanding the known risks,” the prescribing physicians testified that “they stand by their decisions to prescribe”), aff’d , 747 F.3d 26, 2015); In re Plavix Product & Marketing Cases , 2017 WL 2882212, at *3 (Cal.

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59

Drug & Device Law

AUGUST 3, 2023

Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. It turns out that our first post ended up describing the second worst case of the year. It also turns out the we were prescient, because the Louisiana Supreme Court ended up reversing the trial verdict for a number of the reasons we flagged.

Doctors 52

Doctors Packaging FDA FDA Approval 52

Drug & Device Law

MARCH 16, 2022

In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.”

FDA 69

FDA Production Government Marketing 69