The Pharma Data

SEPTEMBER 7, 2021

5.500% Notes due 2027. 3.100% Notes due 2027. and Citigroup Global Markets Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. 284,112,000. 1.750% due August 15, 2041. 5.550% Notes due 2037. 532457 BA5. 476,152,000. 1.750% due August 15, 2041. 532457 AZ1. 377,505,000.

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The Pharma Data

JANUARY 26, 2021

As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. billion by 2027. About Q BioMed Inc. Q BioMed Inc.

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Agency IQ

AUGUST 25, 2023

The most recent reauthorization, BsUFA III, extended the program for fiscal years 2023 through 2027, and was authorized at the end of 2022. In these cases, “such text should be written in a manner that does not imply” that the biosimilar product is licensed for these additional use(s). Featuring previous research by Rachel Coe.

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Biosimilars FDA Production Licensing 40

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. Priority A List. Priority B List.

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Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The illicit marijuana market remains strong despite state laws legalizing marijuana. As state attorneys general, they are concerned about the illicit market, unregulated intoxicating hemp-derived cannabinoids, and the proliferation of dangerous opioids.

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Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. Market-based mechanisms include water quality trading under the Clean Water Act (CWA), an approach that may cost less than more traditional regulatory approaches. EPA is reviewing the comments received and is planning to issue a final rule.

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