Agency IQ

MARCH 7, 2024

The appropriations package refers to the FDA’s ongoing work on diagnostics policy, which has been an extremely active area for policymaking over the last few months [ See AgencyIQ’s analysis, “CDRH diagnostics update: An IVD down-classification initiative, CDx and LDTs, and next steps for diagnostics regulation ].

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Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. Healthy patients who would otherwise not need treatment cannot seek extended coverage. drugs and biologicals. Limitations.

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Clinical Trials Trials Compliance FDA Approval 52

Codon

FEBRUARY 23, 2025

government issued a limited waiver that let PEPFAR resume HIV treatments abroad, pending further guidance. Researcher Jerome Horwitz at the Michigan Cancer Foundation developed it as a potential cancer treatment by chemically-modifying thymine, a DNA building block. By February, the U.S.

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Drug & Device Law

DECEMBER 21, 2023

We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are. Holley also allowed a “pre-approval” warning claim to escape preemption, largely on the same rationale.

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FDA Approval FDA Drugs Production 52

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

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FDA Approval Pharmacy FDA Production 111

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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Drug & Device Law

FEBRUARY 2, 2023

2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. . . . Novartis Pharmaceuticals Corp. , 2d 898, 909-10 (W.D. 2013); Massa v. Genentech Inc. Hoffman-La Roche, Inc.

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Drug & Device Law

MAY 26, 2022

In Hand , the court tackled a range of issues, but the part that stands out to us is the treatment of the misrepresentation-based claims, even with the court’s unwieldy preemption rulings in the way. The BHR court dug in to an extent many MDL court do not in granting summary judgment in In re BHR (Hand v. Smith & Nephew) , No.

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Doctors FDA FDA Approval Production 59