2016 Clinical Pharmacology Drug Development 
The Premier Consulting Blog
JUNE 18, 2023
This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
Drug Target Review
JULY 4, 2023
The authors also explore the need for further data to improve understanding and refine drug design with safety and efficacy in mind. Antibody drug conjugated with cytotoxic payload. antibody linked to a biologically active cytotoxic (anticancer) payload or drug 3d rendering. Translational and Clinical Pharmacology [Internet].
New Drug Approvals
SEPTEMBER 13, 2024
4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] However, development for these indications was discontinued. [2]
Agency IQ
FEBRUARY 23, 2024
Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.
Agency IQ
DECEMBER 11, 2023
Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.”
Agency IQ
OCTOBER 27, 2023
The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. December 2023 Medical Devices; Quality System Regulation Amendments (Final Rule) FDA intends to harmonize and modernize the Quality System regulation for medical devices.
Agency IQ
DECEMBER 1, 2023
The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. December 2023 Medical Devices; Quality System Regulation Amendments (Final Rule) FDA intends to harmonize and modernize the Quality System regulation for medical devices.
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