Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

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Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3210 Accelerated Approval : FDA’s Accelerated Approval Council must publish a report within one year of the passage of the FDORA legislation regarding its annual activities. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

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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.

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Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , Takeda Pharmaceutical Co. , Thus, “[o]ne supposed ‘nightmare’ trial is preferable to many hundreds of shorter ones.”

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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. 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). They excluded bogus expert testimony under Fed. Bonta , 85 F.4th Monsanto Co. ,

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Drug & Device Law

APRIL 18, 2022

The trial court granted summary judgment based on evidence that the implanting surgeon “would have used the clips in the surgery even if he had received such a warning” and thus plaintiff “could not prove the cause element of his claims.” Wyeth Pharmaceuticals , 471 F. Even then Rennick ’s rationale didn’t do a very good job.

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