As we have noted in this blog on several occasions, under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all new drug applications for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration are required to contain an assessment of the safety and effectiveness of the product [...]
Archive for the 'How to:' Category
Pediatric Assessments in Drug Development: timing in Europe vs. US
Published February 5th, 2010 in 505(b)(2) Issues, How to: and Uncategorized. 0 Comments505(b)(2) NDA Preparation Process
Published January 26th, 2010 in 505(b)(2) Process and How to:. 0 CommentsCamargo is fully prepared to create, submit and manage the review of an NDA, either 505(b)(1) or 505(b)(2). Generally, we submit the NDA electronically, so we’re submitting an eCTD.
1. An individualized secure shared website for Camargo and the Client’s project is created for document control. A folder structure is set up according to the Client’s [...]
Analytical Requirements for Oral Solutions
Published January 7th, 2010 in CMC Issues and How to:. 0 CommentsAnalytical requirements for the NDA submission of an oral solution to the FDA are very similar to those requirements for any new drug product. The analytical methods that are used for the testing of an oral solution at the NDA stage of development should be fully validated per the ICH guidelines, Q2A and Q2B, now
ICHQ2(R1) [...]
Questions and Answers on the topic of Authorized Generics
Published December 21st, 2009 in ANDA's and How to:. 0 CommentsWhat would be the regulatory path for an Authorized generic, in general?
Authorized Generics (AG) are prescription drugs that are produced by the NDA holder and marketed under a private label, at generic prices. This circumstance typically presents itself when the NDA holder still has patent protection for the product on the market. Authorization of a [...]
Does Europe have a pathway for approval of drugs analogous to the FDA’s 505(b)2 pathway?
Published November 4th, 2009 in 505(b)(2) Process and How to:. 0 CommentsAs readers of this blog will know, a 505(b)(2) application is a US NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Under the right circumstances, either a new chemical entity [...]
A New Paradigm for the Development of Drugs for Type 2 Diabetes
Published November 4th, 2009 in 505(b)(2) Issues and How to:. 0 CommentsDue to Camargo’s on-going client projects in this area, our chief medical officer, Dr. Sam Kaba recently attended a DIA-sponsored conference in Washington, D.C. entitled Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications: Current State of the Art and Opportunities to Advance the Science. His report:
The FDA Guidance for Industry on Evaluating Cardiovascular [...]
On 30 September 2009, the FDA issued a new draft guidance for industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications. The guidance describes the content and format of a REMS, which the FDA was authorized to require by provisions of the FDA Amendments Act (FDAAA) [...]
Is there a market for your drug?
Published October 19th, 2009 in How to: and Uncategorized. 0 CommentsAt Camargo, we can help clients evaluate the market potential of their proposed drug product by examining factors that might influence the resulting medical position at the time of product launch. When desired or needed for potential fund-raising, we can also perform a full marketing forecast. One aspect of this is to look at market [...]
Test Specifications for Stability Studies
Published September 1st, 2009 in 505(b)(2) Process, CMC Issues, How to: and Outsourcing. 0 CommentsPivotal stability programs that are used to generate stability data for NDA submissions are different than research stability programs used to design the drug product, explore packaging configurations, etc. This is common sense, but we have seen instances of pivotal stability programs that have been performed for clients with no defined specifications. A stability protocol [...]
Electronic filing of eCTD INDs
Published June 9th, 2009 in 505(b)(2) Process and How to:. 0 CommentsAs large amount of documentation and data are required in IND submissions, the Electronic Common Technical Document (eCTD) format is a wise choice for the submission of INDs to the FDA. Camargo’s experience with filing INDs in the eCTD format includes a very recent eCTD IND application accepted by the FDA’s Division of Anesthesia, Analgesia [...]
