Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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FDA Science Regulations Production 40

Agency IQ

AUGUST 4, 2023

These features should not be included on outer packaging or immediate packaging, if there is no outer packaging. Last week, the MHRA provided a roadmap for upcoming labeling requirements, based on license type The Windsor Framework allows the MHRA to approve medicines for U.K. wide license: The requirements of the E.U.

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The Pharma Data

AUGUST 3, 2021

In July, the FDA accepted the Biologics License Application and granted Priority Review for tezepelumab for the treatment of asthma. In anticipation of future demand for our medicines, we will invest approximately $1 billion to build two new manufacturing facilities – a packaging plant in Ohio and a drug substance plant in North Carolina.

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Biosimilars Production Treatment FDA 52

Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

The EPA is also proposing our response to a petition regarding the continued validity of EPA’s 2012 determination (and September 2017 affirmation) that participation in the Cross State Air Pollution Rule (CSAPR) meets the Regional Haze Rule’s criteria for an alternative to the application of source-specific BART.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

FDA 40

FDA Science Biosimilars Regulations 40