Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc.

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Agency IQ

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. Net Revenues of $4.305 Billion and International Profit Sharing of $1.009 Billion; Global Venclexta Net Revenues Were $1.337 Billion. Percent on a Reported Basis, or 13.4

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Production International Clinical Trials Small Molecule 52

The Pharma Data

APRIL 27, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. reflecting lower treatment compliance during the COVID-19 pandemic. In February, Libtayo ® was approved in two new indications in the U.S.

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Vaccine Production FDA FDA Approval 52

The Pharma Data

OCTOBER 29, 2020

Treatment compliance rates across all our medicines have remained strong and continue to be slightly above expectations. We have also seen the predicted slowing of new patient initiations and delays in treatment starts, and we are continuing to closely monitor this environment as the pandemic continues. Eastern Time. Eastern Time.

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Internal Medicine. and four additional selling days in international markets. REVENUES. . . . . . ($ in millions). First-Quarter. . 1,611. . *. *.

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Vaccine Production FDA Clinical Trials 40

FDA Law Blog: Biosimilars

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., Currently Accepted Medical Use in Treatment in the U.S. and lacked accepted safety for use under medical supervision. 21 U.S.C. § 21 U.S.C. § Basis at 63-64.

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Regulations FDA Licensing Licensing 69

FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.; 21 U.S.C. §

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FDA Treatment FDA Approval Drugs 111

FDA Law Blog: Biosimilars

MAY 5, 2024

Scheduling Under the CSA Substances in schedule I of the CSA have a high potential for abuse, no currently accepted medical use in treatment in the U.S., Those in schedule III have a potential for abuse less than schedule I or II substances, have a currently accepted use in treatment in the U.S., 21 U.S.C. § 21 U.S.C. §

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FDA Regulations Treatment Licensing 95