The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package.

Treatment 52

Treatment Drugs Clinical Pharmacology Clinical Development 52

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

Agency IQ

OCTOBER 6, 2023

For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process. However, the record for the highest number of AAs in one year is 16, from FY 2020.

FDA 52

FDA Biosimilars Science Drugs 52

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.”

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

FDA finalized a ban on these devices in 2020, but the D.C. FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.” Circuit vacated the final rule in 2021. With FDA’s LDT rule under development, we wonder if HPM could receive a response soon.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

FDA finalized a ban on these devices in 2020, but the D.C. FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.” Circuit vacated the final rule in 2021. With FDA’s LDT rule under development, we wonder if HPM could receive a response soon.

FDA 40

FDA Science Regulations Production 40