Drug Target Review

SEPTEMBER 19, 2023

In spite of current success and possibility to be a successful cell technology model, the integration of organ-on-chips into drug development process needs more optimisation to be validated for FDA approval.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

NIH Director's Blog: Drug Development

JUNE 14, 2016

That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. December 2008. [2] References : [1] Guidance for industry diabetes mellitus—Evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes.

Drugs 52

Drugs Disease Drug Development Clinical Trials 52

The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

Hospitals 52

Hospitals FDA Approval FDA Treatment 52

Metabolite Tales Blog

MAY 12, 2023

In 2021, almost one third of FDA approved drugs contained at least one fluorine. Journal of Medicinal Chemistry 2008 51 (14), 4239-4252, [link] [12] Overcoming Time-Dependent Inhibition (TDI) of Cytochrome P450 3A4 (CYP3A4) Resulting from Bioactivation of a Fluoropyrimidine Moiety. Kuo, Nancy E. Kohl, and George D.

Drugs 52

Drugs Small Molecule Metabolic Stability FDA Approval 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

FDA 40

FDA FDA Approval Production Regulations 40

FDA Law Blog: Biosimilars

APRIL 30, 2023

1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights in the wake of an adverse FDA approval decision. 110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub.

FDA 59

FDA Biosimilars Regulations FDA Approval 59

Agency IQ

OCTOBER 6, 2023

While stimulant use disorder is increasing, there are currently no FDA-approved medications. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), “between 2008 and 2015, amphetamine-related hospitalizations more than tripled, increasing from 55,447 instances to 206,180.

FDA 40

FDA Treatment Production Trials 40

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval FDA Clinical Trials Treatment 52

The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. Xarelto is approved in more than 130 countries, although the approved labelling, including the number of indications may differ from country to country.

FDA 52

FDA Clinical Trials Treatment Therapies 52

FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. The federal telemedicine flexibilities (i.e., Thus, while continuing to review industry feedback, DEA is still working on promulgating a more workable final set of telemedicine regulations.

FDA Approval 52

FDA Approval Regulations Pharmacy Licensing 52

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.

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

NOVEMBER 2, 2023

Qualifying compounding pharmacies do not require FDA approval to sell compounded drugs. The defendant in Zyla is a qualifying compounding pharmacy that sells without FDA approval a compounded product containing the active ingredient found in the plaintiff manufacturer’s FDA-approved product. Mukasey , 536 F.3d

Compounding Pharmacies 59

Compounding Pharmacies Pharmacy FDA Approval FDA 59

Drug & Device Law

SEPTEMBER 22, 2023

2008), shows how the OTC express preemption provision should work. 312 (2008), and considering 21 U.S.C. If the lawsuit falls into any other bucket—such as economic loss claims—it is preempted. An older case, Carter v. Novartis Cons. Health, Inc. , 2d 1271 (C.D. Next, addressing 21 C.F.R. 379r right after the U.S. Medtronic, 552 U.S.

Drugs 105

Drugs Regulations Production FDA Approval 105

Drug & Device Law

SEPTEMBER 18, 2023

FDA, CDER, “Guidance for Industry − Medical Device Reporting − Alternative Summary Reporting (ASR) Program, 2000 WL 34503093, at *1 (Oct. Medical device manufacturers could “request[ FDA] approval to participate in the ASR program.” Id. 312 (2008). 9, 1999), appeal quashed , 750 A.2d 2d 381 (Pa. Medtronic, Inc. ,

FDA 59

FDA Regulations FDA Approval Production 59

Drug & Device Law

JULY 18, 2023

As evidenced by our PMA Preemption Score Card , on which today’s case became the 651 st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions. 312 (2008). Since that would encroach on the FDA’s regulatory authority, this claim is also expressly preempted.

FDA Approval 52

FDA Approval FDA Regulations Government 52

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. 3d 281 (6th Cir.

FDA Approval 64

FDA Approval FDA Regulations Production 64

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. Lederle Laboratories , 2008 WL 972657 (W. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. 2d at 401.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Albrecht , 139 S. 2019), or Mutual Pharmaceutical Co. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Albrecht , 139 S.Ct.

FDA 72

FDA Regulations Production Government 72

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. An unfortunate fiction developed post- Buckman —particularly after Riegel v.

FDA 59

FDA Regulations FDA Approval Production 59

Drug & Device Law

OCTOBER 10, 2022

The drug at issue is the only FDA-approved pharmaceutical treatment for ATTR-CM (although off-label use of other drugs, and organ transplant, are sometimes used as treatments). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

Drugs 52

Drugs FDA Approval FDA Disease 52

Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. 660, 664 (1962).

FDA Approval 116

FDA Approval FDA Drugs Regulations 116

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. See this post on one of our decisions from 2008.) Hiedeman, 694 F.3d

FDA Approval 127

FDA Approval Pharmacy FDA Drugs 127

Drug & Device Law

APRIL 18, 2022

at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval. 2008); Herzog v. Apparently, the “no warnings” issue arose because physician in Rennick put the product to an off-label use, id. Even then Rennick ’s rationale didn’t do a very good job.

Testimonials 59

Testimonials Production FDA Approval FDA 59

Drug & Device Law

APRIL 15, 2022

The defibrillator is a Class III device, which means it underwent the FDA’s full premarket approval (PMA) process before it was approved for marketing. 312 (2008), state law design defect claims against manufacturers of Class III devices are expressly preempted by the medical device amendments to the FDA.

FDA Approval 59

FDA Approval FDA International Production 59

Drug & Device Law

MARCH 31, 2022

Medicare covers quite a few off-label uses, because the relevant term – “medically accepted indication” – includes all drug uses, whether or not FDA-approved, that are “supported by one or more citations included or approved for inclusion in any of the [certain medical] compendia.” 1396r-8(k)(6).

FDA Approval 40

FDA Approval Government FDA Disease 40

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

FDA 52

FDA Regulations Science Drugs 52