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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Broad Institute

APRIL 25, 2024

Since 2007, they’d been studying Lassa fever, an often deadly illness caused by infection with the Lassa virus, which is endemic in West Africa. Sentinel is also developing a SHINE test to detect Lassa virus in rural clinics in Nigeria, where there are currently no FDA-approved diagnostics for the disease.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014. FDA, since 1991, had publicly signaled that the opening of an INAD file starts the testing phase for a new animal drug. FDA also consistently interpreted it that way between 1990 and 2007.

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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. 110-85 (2007), as amended by Section 301 of Pub. That bill is S.

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Agency IQ

JUNE 2, 2023

The FDA first proposed a rule on “Prescription Drug Labeling: Medication Guide Requirements” in 1995 , which was finalized in 1998. However, over the last decade the FDA and other stakeholders have acknowledged that there are opportunities for improvement. After all, companies already have FDA-approved labels.

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Agency IQ

JUNE 7, 2024

These products are also required to comply with certain labeling expectations and manufacturers are expected to follow a specific set of current good manufacturing practices ( a final rule issued in 2007). Dietary supplement products do not need approval prior to being marketed – unless they contain a new dietary ingredient (NDI).

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The Pharma Data

MAY 16, 2021

Plus, many of these kits claimed to be EU or FDA approved, when they were anything but… Quite simply, they were ILLEGAL, but I was still able to buy them online – and so can you. s one from The Daily Mail in the UK, which was highlighting the risks all the way back in 2007… And very little has changed since then!

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

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Agency IQ

MARCH 7, 2024

As AgencyIQ has previously discussed , the Tropical Disease PRV program was actually the first of FDA’s voucher programs, introduced in 2007 to incentivize the development of products to treat diseases (i.e., In January 2024, the FDA approved the first-ever importation plan , from the state of Florida.

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Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. in 2007, deeming a clinical trial to be qualifying by solely pointing to the seven desirable characteristics below is not recommended.

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Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. von Eschenbach , 495 F.3d 3d 695 (D.C. von Eschenbach , 525 F. 2d 952 (S.D.

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Drug & Device Law

DECEMBER 21, 2023

We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are. Holley also allowed a “pre-approval” warning claim to escape preemption, largely on the same rationale.

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Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

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Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

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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. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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Drug & Device Law

FEBRUARY 2, 2023

2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. Texas has a rebuttable presumption that FDA-approved prescription drug labels are adequate, and Plaintiff here is unable to rebut that presumption. Novartis Pharmaceuticals Corp. , 2d 898, 909-10 (W.D. 2013); Massa v. Genentech Inc. 2012 WL 956192, at *5 (S.D.

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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. 124 (2007), which would also be knocked out by Dobbs if it sticks.

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Drug & Device Law

MAY 26, 2022

After attending a patient education class, seeking a second opinion, being warned that she was at increased risk for revision as a woman, and being warned of a risk of metal ions accumulating in her blood, she went forward with the BHR implant in her left hip on June 25, 2007. at *7 (citing the case discussed here ).

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Drug & Device Law

MARCH 31, 2022

We discussed these concerns – which have since crystallized into what is called either the “municipal cost recovery rule” or the “free public services doctrine” – more detail back in one of the Blog’s early(2007) posts. In other words, the generic manufacturers are not allowed to change the FDA-approved label.

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