2001, FDA Approval and Trials - Drug Discovery Digest

The evolution and future of gene therapy

Drug Discovery World

OCTOBER 12, 2023

His work remains a key component of every FDA-approved AAV therapeutic and will remain central to future advances. Dr Samulski has advanced therapeutics into human clinical trials for haemophilia, Duchenne muscular dystrophy, giant axonal neuropathy, Pompe disease and heart failure.

Therapies

Therapies FDA Approval Clinical Trials Virus

Podcast: The evolution and future of gene therapy

Drug Discovery World

OCTOBER 12, 2023

His work remains a key component of every FDA-approved AAV therapeutic and will remain central to future advances. Dr Samulski has advanced therapeutics into human clinical trials for haemophilia, Duchenne muscular dystrophy, giant axonal neuropathy, Pompe disease and heart failure.

Therapies

Therapies FDA Approval Clinical Trials Virus

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

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science

Science FDA Packaging Production

DARPA Neurotechnology: The Deep Dive

Codon

MARCH 28, 2023

There was nothing left over for human trials, until an opportune call came from Elon Musk’s secretary. The money was earmarked for human trials and, afterward, to develop a neural prosthesis that could augment memories in healthy adults. ” Musk later wrote a check for one million dollars.

Engineering

Engineering Research Science FDA Approval

Another RICOdiculous Decision

Drug & Device Law

JULY 24, 2023

What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co. 341 (2001). Second, as for superiority, PATDC82 II admitted that a class trial would face “enormous logistical hurdles,” but nonetheless found a nationwide class action “superior.” Plaintiffs Legal Committee , 531 U.S.

Testimonials

Testimonials Pharmacy FDA Doctors

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. Danco Labs., See 21 U.S.C.§

FDA

FDA FDA Approval Pharmaceuticals Clinical Trials

Split Decision

Drug & Device Law

MARCH 31, 2022

In other words, the generic manufacturers are not allowed to change the FDA-approved label. Nor was a mere trial court free to invent new causes of action. “[I]t is not this Court’s role to adopt novel causes of action. 2001) (“irrespective of the theory of recovery. . . E.g. , Ford Motor Co. 2d 362, 370 (Md.

Government

Government Production FDA Approval FDA

Logical Contradiction Doctrine: Buckman for Textualists

Drug & Device Law

JANUARY 30, 2023

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. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Albrecht , 139 S.Ct.

FDA

FDA Regulations Production Government

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

Drug & Device Law

SEPTEMBER 1, 2023

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)— about a year later. So the plaintiffs pivoted. That is how we got to oral argument in the California Court of Appeal.

Production

Production Marketing Pharma Companies FDA Approval

Fallacious FDA Reporting Claim Finally Falls

Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications.

FDA

FDA Regulations FDA Approval Production

Court Denies Motion to Dismiss Claims Targeting a Biologic

Drug & Device Law

SEPTEMBER 29, 2022

Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” Once approved, a biologics label generally may not be changed without prior FDA approval. 341 (2001). Albrecht , 139 S.

FDA

FDA FDA Approval Licensing Licensing

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.” at 237-38.

FDA

FDA FDA Approval Testimonials Vaccine

Life-Saving Drugs and Chicken Bones: California Court Expands Innovator Duties of Care

Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. The court also assumed that physicians naturally would prescribe the “newer” TAF once the FDA approved it. at *48-*50.

FDA Approval

FDA Approval Drugs Production FDA

Drug Discovery Digest

The evolution and future of gene therapy

Podcast: The evolution and future of gene therapy

Trending Sources

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

DARPA Neurotechnology: The Deep Dive

Another RICOdiculous 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

Split Decision

Logical Contradiction Doctrine: Buckman for Textualists

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

Fallacious FDA Reporting Claim Finally Falls

Court Denies Motion to Dismiss Claims Targeting a Biologic

The FDA and Feasible Alternative Designs

Life-Saving Drugs and Chicken Bones: California Court Expands Innovator Duties of Care

Stay Connected