The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S. for the treatment of diabetes.

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Biosimilars Production FDA Approval FDA 52

FDA Law Blog: Biosimilars

MARCH 29, 2023

Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and grab a box off the shelf in the coming days. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S.

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Pharmacy FDA FDA Approval Production 105

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.

Science 40

Science Biosimilars FDA Production 40

FDA Law Blog: Biosimilars

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners. 53,688 (Aug. 53,767 (Aug.

Regulations 59

Regulations Pharmacy Licensing Licensing 59

FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. Section II at 2. Draft Guidance III.B.2(e)

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FDA FDA Approval Licensing Licensing 52

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

TAB, CAP, ML, EA), drug type (prescription or OTC), base date AMP, therapeutic equivalent code, line extension indicator, 5i indicator, 5i route of administration (if applicable), FDA approval date, FDA application number or OTC monograph citation (if applicable), market date, and covered outpatient drug status.

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Drugs Regulations International Production 59

Agency IQ

SEPTEMBER 29, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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FDA Science Regulations Production 40