Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. On August 20, 2018, the Company signed the Exclusive Dealing Agreement with Prof.

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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.

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The Pharma Data

FEBRUARY 8, 2021

Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “In In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”.

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Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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