Agency IQ

SEPTEMBER 22, 2023

The FDA-required labeling is the drug labeling that is submitted by the sponsor and reviewed and approved by the FDA as part of the drug’s marketing application (including a New Drug Application, Abbreviated NDA, or a Biologics License Application) – and includes prescribing information (PI).

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. What is noteworthy about this proposed definition is that it adds a new requirement that “[a] manufacturer must make data available to CMS to support its finding.”

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Agency IQ

FEBRUARY 12, 2024

This is a topic that seems highly related to a recent report from the Reagan-Udall Foundation for the FDA focused on “enhancing post-market evidence generation for medical products” that calls for a “learning health care system.”

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

The PR goes on to state that the FD&C Act definition of a device does not turn on where or by whom a test system is “manufactured.” FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice.

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority A List. Priority B List.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis. FDA had not approved any drug product for marketing containing marijuana so DEA applied a five-part test it had established when denying marijuana rescheduling in 1994. 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

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The Pharma Data

FEBRUARY 8, 2021

Business net income is a non-GAAP financial measure (definition in Appendix 9). 1 See Appendix 9 for definitions of financial indicators. to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. Full-year 2020, BOI increased 4.4% to €9,762 million.

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The Pharma Data

FEBRUARY 4, 2021

Business net income is a non-GAAP financial measure (definition in Appendix 9). 1 See Appendix 9 for definitions of financial indicators. to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. Full-year 2020, BOI increased 4.4% to €9,762 million.

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The Pharma Data

APRIL 27, 2021

and strong uptake in global markets, including China. Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7) (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. 2021 first-quarter Sanofi sales.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. Non-applicable drugs (e.g.,

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The Pharma Data

NOVEMBER 9, 2020

The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 7 Wenzel S.

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Agency IQ

DECEMBER 1, 2023

fit in this definition. The following PDUFA dates were obtained from publicly available sources. Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig.

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The Pharma Data

DECEMBER 21, 2020

The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Wenzel S.

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Agency IQ

JUNE 2, 2023

Given the number of approved drugs and biologics on the market that are dispensed on an outpatient basis – and their generic and biosimilar equivalents – the additional workload on FDA’s labeling review staff could be considerable. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

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