Blog Clinical Pharmacology Packaging 
The Premier Consulting Blog
JULY 31, 2024
In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.
The Premier Consulting Blog
SEPTEMBER 11, 2024
The 505(b)(2) submission for Bendeka included a complete chemistry, manufacturing, and controls (CMC) package, but relied on the drug master file (DMF) for Treanda. The overall development strategy for GT123 was to include a complete CMC package. daily versus four times daily dosing).
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
The Premier Consulting Blog
NOVEMBER 4, 2023
In general, such meetings are multidisciplinary and cover the regulatory, Chemistry, Manufacturing, and Controls (CMC), non-clinical, and clinical plans for a development program. In this blog, we share valuable insights and considerations for conducting an optimal assessment in preparation of such meetings from the CMC perspective.
FDA Law Blog: Drug Discovery
DECEMBER 6, 2024
The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. The draft guidance recommends that no more than 15 questions are included in the briefing package.
Expert insights. Personalized for you.
52 
Let's personalize your content