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.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. 2008 Mar;153 Suppl 1(Suppl 1):S82-9. We hope it was a useful two-parter!

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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.

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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.

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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.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Another case of same-day (and same-time) FDA approvals! To that end, 35 U.S.C. § 156(c)(4)

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Molecule Blog

AUGUST 13, 2021

If successful, this work could result in the repurposing of several FDA-approved therapeutics for the purpose of extending the human lifespan, at a lower cost and over faster timelines than conceivably possible with de novo drug discovery. The Scheibye-Knudsen lab has analyzed 1.5 billion prescriptions from 4.8

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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.

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Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. 2008) 118:3132–3142. Journal of Translational Medicine.

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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.

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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.”

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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.

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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.

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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. ,

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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.

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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

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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.

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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.

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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).

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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. ,

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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.

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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.

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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.

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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.

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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.

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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

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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).

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