2001, Drugs, FDA Approval and Pharmaceuticals

2001

Drugs

FDA Approval

Pharmaceuticals

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

Science

Science FDA Packaging Production

Another Update on Medical Abortion Litigation

Drug & Device Law

AUGUST 28, 2023

In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. FDA , 727 F.

FDA

FDA FDA Approval Doctors Production

Join 15,000+

Insiders

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

Another Update on Medical Abortion Litigation

Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. FDA , 727 F. 1, 6 (D.D.C.

FDA Approval

FDA Approval FDA Doctors Production

Another RICOdiculous Decision

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. , This litigation does not allege that anybody ever actually suffered from bladder cancer (or any other injury) from the drug.

Testimonials

Testimonials Pharmacy FDA Doctors

A Painful Preemption Decision

Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. ASH-ADHD is illustrative of the big difference that the “product liability” exception to express preemption for OTC drugs makes.

Regulations

Regulations Nurses FDA FDA Approval

Yet Another Update on Medical Abortion Litigation: PhRMA’s Amicus Brief in Support of Petition for U.S. Supreme Court Review of the Fifth Circuit Decision

Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. FDA , 727 F.

FDA

FDA FDA Approval Pharmaceuticals Clinical Trials

Logical Contradiction Doctrine: Buckman for Textualists

Drug & Device Law

JANUARY 30, 2023

The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. 341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court.

FDA

FDA Regulations Production Government

California Court Considers Expanding Tort Law in “Duty to Innovate” Case

Drug & Device Law

SEPTEMBER 1, 2023

a panel of the California Court of Appeal is considering whether a prescription drug manufacturer can be liable in tort not for a product defect, but for negligence in failing to develop a different, allegedly safer product sooner than it actually did. First Dist.), No court has allowed this. See, e.g., here and here. Keep that in mind.

Production

Production Marketing Pharma Companies FDA Approval

Another Reason Why The FDA, Not Litigants, Approves Products

Drug & Device Law

FEBRUARY 11, 2024

Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court: The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations.

FDA

FDA Production FDA Approval Regulations

Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer

Drug & Device Law

FEBRUARY 15, 2024

Today’s guest post is by Sherry Knutson and Brenda Sweet of Tucker Ellis , and concerns the recently passed legislative repeal of a Michigan statute that, for several decades had effectively immunized prescription drugs from ordinary product liability actions under Michigan law. Lynch & Co. Flex Techs., 2d 180, 182 (Mich.

Production

Production FDA Approval Compliance FDA

The FDA and Feasible Alternative Designs

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.”

FDA

FDA FDA Approval Testimonials Vaccine

FDA’s Rules are FDA’s to Enforce

Drug & Device Law

OCTOBER 10, 2023

Plaintiff has listed its patches on the FDA’s National Drug Code (“NDC”) database. Doing so comes with obligations to comply with FDA’s labeling requirements for such OTC drugs, which Plaintiff alleges they do. The Food, Drug, and Cosmetic Act (“FDCA”) does not contain a private right of action. 341 (2001).

FDA Approval

FDA Approval FDA Pharmacy Regulations

Preemption and OTC Drugs

Drug & Device Law

SEPTEMBER 22, 2023

in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. Federal preemption involving OTC drugs is the subject of today’s musings. As Carter recounts, starting in 1976, FDA developed the OTC Cough and Cold Monograph, 21 C.F.R. 379r(a)(1). 379r(a)(1). 379r(c)(2).

Drugs

Drugs Regulations Production FDA Approval

Bexis Publishes Article Applying FDCA Preemption to Medication Abortions

Drug & Device Law

OCTOBER 6, 2023

He proposed writing his own law review article on this subject – about which he knows as much as anyone – to the Food & Drug Law Institute. 341 (2001), (2) impossibility preemption barring “stop selling” claims under Mutual Pharmaceutical Co. 472 (2013), and (3) express OTC drug preemption under 21 U.S.C. 109 (2023).

FDA Approval

FDA Approval FDA Production Science

Drug Discovery Digest

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Another Update on Medical Abortion Litigation

Trending Sources

Another Update on Medical Abortion Litigation

Another RICOdiculous Decision

A Painful Preemption Decision

Yet Another Update on Medical Abortion Litigation: PhRMA’s Amicus Brief in Support of Petition for U.S. Supreme Court Review of the Fifth Circuit Decision

Logical Contradiction Doctrine: Buckman for Textualists

California Court Considers Expanding Tort Law in “Duty to Innovate” Case

Another Reason Why The FDA, Not Litigants, Approves Products

Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer

The FDA and Feasible Alternative Designs

FDA’s Rules are FDA’s to Enforce

Preemption and OTC Drugs

Bexis Publishes Article Applying FDCA Preemption to Medication Abortions

Stay Connected