Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Drug Target Review

SEPTEMBER 5, 2024

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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Agency IQ

JUNE 2, 2023

The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

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Agency IQ

FEBRUARY 12, 2024

However, the FDA does not publish a singular guidance agenda; rather, it publishes separate agendas from each major product review center (CBER, CDER, CDRH, CFSAN), as well as some additional FDA offices (like its Office of the Chief Scientist ). This list is known as the FDA’s “guidance agenda.”

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Administrative, Procedural Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564 CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority A List. Called for under MDUFA. Priority A List.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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The Pharma Data

OCTOBER 15, 2020

Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics. Shashank joins Trevi from Metrum Research Group where he was senior principal scientist for Clinical Pharmacology. Floyd co-founded Elion Oncology which licensed PCS6422 to Processa.

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Agency IQ

SEPTEMBER 29, 2023

An avalanche of new legislation: Speaking of Congress, the House and Senate are back in session as of mid-September and we have already noticed a lot of legislative interest in the FDA – probably about two dozen bills related to drug shortages, generic drug competition, supply chain security, opioids, medical device recalls and orphan drug products.

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Agency IQ

DECEMBER 1, 2023

This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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Agency IQ

MARCH 1, 2024

As it happens, EtO is essential for the sterilization of many medical devices, and the EtO final rule is expected to kick off a frantic period for regulators as they try to authorize substitute methods for device sterilization and ensure device products do not go into shortage. This is what OIRA is currently reviewing.

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Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot. This is what OIRA is currently reviewing.

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FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

Tobolowsky — The neonatal period is a unique and complex period of rapid growth and development throughout the body, thus creating unique and complex challenges in medical product development for this population. However, even products with single doses may require long-term safety assessments based on other considerations.

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Agency IQ

JULY 12, 2024

The latest Spring 2024 Unified Agenda contains 53 regulations that FDA plans to publish related to human medical product regulation. The proposed amendment will clarify and modernize the regulations by adding requirements for quality management systems and controls over components and drug product containers and closures. and the E.C.

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