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Clinical Pharmacology Considerations for Peptide Drug Products

thought leadership

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. These products fall somewhere between drugs and biologics and do not have the usually well-defined characteristics of either category. A peptide is any polymer with 40 or fewer amino acids.

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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law Blog: Drug Discovery

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations.

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Women in STEM with Kristina Torfgard

Drug Target Review

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Shaping drug development success: how does artwork play a role?

Drug Target Review

While the entire lifecycle of the development process must be carefully navigated, and as the life sciences sector develops, there will be more significant investment in the preclinical stage, specifically around labelling and artwork. Precise labelling and artwork help prevent confusion and enhance overall patient safety.

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AdComms – Is FDA Getting Less Advice?

Eye on FDA

FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product approvals. As more drugs are being approved, is FDA getting less advice than in the past? There are 31 advisory committees on matters ranging from food to medical devices to pediatric care.

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Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

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.

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FDA Advisory Committee Review of 2021

Eye on FDA

And a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee is meeting jointly with the Drug Safety and Risk Management Advisory Committee on February 15 to consider an NDA in the pain category. But before heading into 2022, it is perhaps time to take stock of AdComms and what they did or did not do during 2021.

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