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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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. About the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. # # #.

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Codon

MARCH 24, 2024

” Even today, the company’s profile on the Flagship Pioneering website knocks the size of “pharmaceutical factories,” which “can run to 800,000 square feet or more,” and touts the beauty of cells as factories, with messenger RNA as their “foreman.”

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The Pharma Data

DECEMBER 29, 2020

Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. About Fabry Disease. Protalix has licensed to Pfizer Inc.

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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 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

NOVEMBER 15, 2022

Korlym was approved by the FDA in 2012. During the approval process, the FDA conducted a Medical Review of the drug which included information about endometrial thickening and the related complications experienced by users. Mensing, Mutual Pharmaceutical Company v. Levine, PLIVA, Inc.

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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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