Clinical Pharmacology, Licensing and Presentation

Trends & Insights: Spotlight Winter Edition

DrugBank

FEBRUARY 9, 2023

1 Present address: Functional Genomics and Metabolism Research Unit, Department of Biochemistry and Molecular Biology, University of Southern Denmark, Denmark. DrugBank Powered Research: Pharmacological knowledge about drug targets was analyzed based on a query of DrugBank. 2 Cancer Program, Broad Institute of MIT and Harvard, USA.

Clinical Pharmacology

Clinical Pharmacology Molecular Biology DNA Licensing

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

FDA

FDA Science Regulations Production

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. Expect nearly every company to be closely reading this document when it’s eventually published.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. QMSR final rule : For years, the FDA has been talking about harmonizing its Quality System Regulation with ISO 13485:2016, which it would incorporate by reference. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. Both sections 503A and 503B provide that a compounded drug is not eligible for those exemptions if it is identified by FDA as presenting demonstrable difficulties for compounding.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Agency IQ

MARCH 1, 2024

Government shutdown: At present, the FDA has appropriated funding lasting until midnight on Friday, March 1. Given that the rule is currently under White House review, we’re expecting this to soon be released. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

FDORA Legislation Antimicrobial FDA will publish a draft guidance describing considerations for developing presentations, container closure systems and device constituent parts for proposed interchangeable biosimilar biological products. Priority B List.

FDA

FDA Science Biosimilars Clinical Trials

FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development

FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

raw scores, standardized norm-referenced scores), some of which might present floor or ceiling effects; and ensuring that selected COAs have demonstrated reliability across demographic groups. Considering that, the safety data generated during clinical trials may not capture all possible delayed adverse events.”

Production

Production FDA Therapies Clinical Pharmacology

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Regulations

Regulations FDA Science Production

Drug Discovery Digest

Trends & Insights: Spotlight Winter Edition

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Webinars

Trending Sources

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Webinars

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

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