Agency IQ

JUNE 16, 2023

The Lime Manufacturing NESHAP, codified in 40 CFR part 63, subpart AAAAA, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on January 5, 2004. Amendments to TSCA in 2016 included several new provisions concerning the assertion and Agency review and treatment of CBI claims. 2020) (LEAN).

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

JULY 13, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004 ( see a Congressional Research Service report on its legislative history here ).

FDA 40

FDA Packaging Laboratories Testimonials 40

Drug & Device Law

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. 2004 WL 7334819, at *18 (Mag. 2004), transfer denied (Mo. Restatement §402A, comments a, d-e. Graphic Process Co. ,

Production 52

Production International Trials Government 52

Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. 2004) (no causation where prescriber “continues to prescribe [similar] medication. . .

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

That oncologists prescribing lifesaving standard-of-care treatment in the face of “aggressive cancer” are not impressed by a risk of – permanent hair loss – is not surprising. 1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. at *3 (emphasis original).

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

MAY 4, 2023

Relatedly, the claim for “false marketing”—the court’s term, whereas the OPLA calls it “Product conforming to representation made by manufacturer” and it would usually be called “misrepresentation”—was really a re-packaged warnings claim. Warner-Lambert & Co. , 3d 85, 98 (2d Cir. 2006), aff’d by equally divided court , 552 U.S.

FDA Approval 64

FDA Approval FDA Regulations Production 64