Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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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. The results of this survey were provided in a report to the AMA’s Council on Scientific Affairs.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. The FDA sought input on these criteria from the PCAC in 2015 and again in 2016.

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The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law.

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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. Bayer Healthcare Pharmaceuticals Inc. 379r(e). 2022 WL 16951538 (S.D.N.Y.

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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. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

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Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. 280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Kent , 552 U.S.

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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 11, 2024

FDA litigation that is now before the Supreme Court. 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. We were hardly alone. & Man’l Epid’y. Longbons T.,

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. .

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Drug & Device Law

SEPTEMBER 22, 2023

in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. 379r(c)(2), Carter also quickly recognized that the OTC preemption “state requirement” prong includes state law causes of action, not just state legislation or regulations. 2015)), Booker v. 379r(a)(1).

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Drug & Device Law

AUGUST 31, 2023

The court dismissed the design-defect claim as pleaded, holding it impliedly preempted under Mutual Pharmaceutical Co. b)(2) not to make such a change without first obtaining FDA approval.” Ortho-McNeil-Janssen Pharmaceuticals, Inc. , Ortho-McNeil-Janssen Pharmaceuticals, Inc. , Bartlett , 570 U.S. 3d 281 (6th Cir.

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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. See Lars Noah, “State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products,” 2016 Mich. Jackson Women’s Health Org. , 2022 WL 2276808 (U.S.

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