2001, FDA Approval, Marketing and Regulations

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

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

Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

Science

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Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The illicit marijuana market remains strong despite state laws legalizing marijuana. The letter is signed by six former DEA administrators and five former Directors of National Drug Policy.

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Another Update on Medical Abortion Litigation

Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important.

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Another Update on Medical Abortion Litigation

Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important.

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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. FDA , 727 F.

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A Painful Preemption Decision

Drug & Device Law

JANUARY 9, 2023

Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves. The FDA also promulgated an acetaminophen-specific OTC regulation. 201.326(a)(1).

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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. Mensing , 564 U.S. Jones , 225 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

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A Texas Mess

Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). & Com.

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Thinking About the FDA’s Alternative Summary Reporting Program

Drug & Device Law

SEPTEMBER 18, 2023

The ASR program was initially open to regulated manufacturers of twelve device categories; Intravascular (I.V.) FDA, CDER, “Guidance for Industry − Medical Device Reporting − Alternative Summary Reporting (ASR) Program, 2000 WL 34503093, at *1 (Oct. an exemption from the individual event reporting requirements.” 888.3050(a).

FDA

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Court Denies Motion to Dismiss Claims Targeting a Biologic

Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. 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.” 341 (2001). See 42 U.S.C. § See 21 C.F.R.

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The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA

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Another Reason Why The FDA, Not Litigants, Approves Products

Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. See Alliance for Hippocratic Medicine v. We were hardly alone. See AHM I , 2023 WL 2825871, at *4 n.9

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

Drug & Device Law

JANUARY 12, 2024

At issue was whether a product manufacturer could be liable to patients taking one drug for failing to bring a different, but allegedly safer drug to market sooner than it actually did. Instead, the plaintiffs claimed that the defendant should have developed and marketed a different drug sooner. Gilead Life Sciences, Inc. at *31-*32.

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FDA’s Rules are FDA’s to Enforce

Drug & Device Law

OCTOBER 10, 2023

Each claim alleges that defendants’ failure to comply with FDA’s regulations is an unfair business practice and/or causes “consumer confusion.” That’s the FDA’s job, not the court’s. 341 (2001). Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval.

FDA Approval

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Drug Discovery Digest

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

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

Trending Sources

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

Another Update on Medical Abortion Litigation

Another Update on Medical Abortion Litigation

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

A Painful Preemption Decision

Logical Contradiction Doctrine: Buckman for Textualists

A Texas Mess

Thinking About the FDA’s Alternative Summary Reporting Program

Court Denies Motion to Dismiss Claims Targeting a Biologic

The FDA and Feasible Alternative Designs

Another Reason Why The FDA, Not Litigants, Approves Products

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

FDA’s Rules are FDA’s to Enforce

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