We’ve been observing the FDA crackdown on unapproved DESI and OTC drugs. The reason that Congress and FDA have made these moves is a concern for safety. Industry counters that these drugs have been used safely for years. Frankly, there is a lack of data to support either side. Approved drugs have always been subject [...]
Archive for December, 2007
New Safety Reporting Requirements for Unapproved OTC products
Published December 24th, 2007 in Events. 0 Comments505(b)(2) - Part 2: The Assessment: CMC Development Plan
Published December 19th, 2007 in 505(b)(2) Process. 0 Comments CMC Development Plan
All too often we see plans that don’t integrate the clinical trial materials with the clinical development plan. This is usually because the people and organizations responsible for each area don’t interact well and there is a lack of overall project management. Most often, the focus of the company is the clinical plan [...]
505(b)(2) - Part 2: The Assessment: Clinical Marketing Assessment
Published December 12th, 2007 in 505(b)(2) Process. 0 Comments Competitive Products Review/Clinical Marketing Assessment
This section includes an assessment of the existence of a medical need and the ability of the proposed drug to compete with existing and pipeline agents. At Camargo we deeply believe that good science = good business. In practice, this means that simply getting FDA approval isn’t enough. The drug [...]
505(b)(2) - Part 2: The Assessment: Regulatory Strategy
Published December 10th, 2007 in 505(b)(2) Process. 0 Comments Regulatory Strategy
This section provides analysis of pertinent regulatory information to produce a recommended regulatory pathway. A thorough search of regulatory documents supports the regulatory recommendations (e.g., Dockets Management; HeinOnline[1]).
The 505(b)(2) regulatory pathway may be appropriate if part of the NDA application requirements can be supplied using information from published literature and/or the Agency’s findings of [...]
505(b)(2) - Part 2: The Assessment: Clinical Development Plan
Published December 10th, 2007 in 505(b)(2) Process. 0 CommentsClinical Development PlanThe proposed Clinical Development Plan is dependent on the selected regulatory pathway. The Clinical Development Plan is based on available Agency study recommendations provided in the FDA Guidance for Industry documents, information in the public domain (e.g., PubMed), and information obtained from SBA documents as applicable.
The plan consists of the outline of each [...]
I have been asked many times where to find the summary basis of approval (SBA) for a drug - usually the reference listed drug (RLD). The first place to try to find the document is at FDA website. If it is not available there, you will need to use a paid service, such as FOI [...]
Audioconference @ FDAnews December 12, 2007 1:30 - 3:00 EST
Published December 7th, 2007 in Events. 0 CommentsI’ve been asked to present an audioconference on the 505(b)(2) process. Someone who attended my workshop at the Drug Repositioning Summit in October, 2007 suggested this to FDAnews. As usual, the sponsor, FDAnews advertised some very aggressive goals (see below) for this 1 hour conference. I hope not to disappoint too many if I can [...]
505(b)(2) - Part 2: The Assessment: Clinical Pharmacology
Published December 7th, 2007 in 505(b)(2) Process. 0 Comments Clinical Pharmacology
An overview of the proposed product’s absorption, distribution, metabolism, and excretion (ADME) is detailed in this section obtained from various resources (e.g., PDR[1], Facts and Comparisons[2], approved product labeling). An important source of information for this and other sections is the FDA reviewer summaries (Summary Basis of Approval - SBA) for the reference listed [...]
505(b)(2) - Part 2: The Assessment: Pharmacokinetic Review
Published December 1st, 2007 in 505(b)(2) Process. 0 CommentsA comprehensive search of the literature is performed to obtain published pharmacokinetic (PK) data for the proposed product (dependent on selected regulatory pathway). This review compares the PK profiles for all available routes and conditions of administration and dose strengths. This review includes studies assessing:
Single- and multiple-dose administration
Dose proportionality
Bioavailability
Dose-ranging studies
Drug-drug interaction studies
Food effects
PK information is essential in [...]
