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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Pharmaceutical Companies Treatment Clinical Trials Trials 52

Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

The FDA DSUR is intended to be consistent with the format and content for IND annual reporting supported by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and is more comprehensive, and informative than the IND annual report currently required by FDA.

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Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3210 Accelerated Approval : FDA’s Accelerated Approval Council must publish a report within one year of the passage of the FDORA legislation regarding its annual activities. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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FDA Science Regulations Production 40