2007, FDA Approval and Regulations - Drug Discovery Digest

2007

FDA Approval

Regulations

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

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Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law Blog: Biosimilars

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R.

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New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

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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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

The FDA recently concluded its work on a proposed rule focused on PMI. The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The FDA first proposed a rule on “Prescription Drug Labeling: Medication Guide Requirements” in 1995 , which was finalized in 1998.

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Analysis Life Sciences Thank You The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s analysis of the draft guidance here. ]

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Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

MARCH 7, 2024

Further, the agency would need to make a separate table finding “at least $8,500,000,” for cosmetics regulation implementation ($7 million of that) and work on finding alternatives to animal testing ($1.5 The budget agreement “asks” the FDA for some information and activities, and “recognizes” some FDA authority in other areas.

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Medicare Coverage Analysis Worksheet

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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Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. 4th 210 (5th Cir. Gilead Sciences, Inc. 2023 WL 6390598 (N.D.

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NPP, DCC, And FDA-Regulated Medical Products

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. The most prominent litigation in this space these days relates to reproductive rights. Ogden , 22 U.S.

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Mifepristone Manufacturer Wins First Round in West Virginia

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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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.

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Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

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.

FDA Approval

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FDA-Approved Labeling: Is Enough Enough?

Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

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Trending Sources

New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Analysis Life Sciences Thank You The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Medicare Coverage Analysis Worksheet

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

NPP, DCC, And FDA-Regulated Medical Products

Mifepristone Manufacturer Wins First Round in West Virginia

The FDA and Feasible Alternative Designs

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

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