Product Description

Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including:

* How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements.

* How the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes.

* How CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process.

* How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions.

* Which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process.


Find out why New Drug Development is pharma/biotech's go-to resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes.

Product Details

• Amazon Sales Rank: #1005147 in Books
• Published on: 2008-01-01
• Original language: English
• Number of items: 1
• Binding: Hardcover
• 362 pages

Review
This book is superb! It is the single best source of information on the drug regulatory system. --Peter Barton Hutt, Covington & Burling

This book provides the most comprehensive and up-to-date analysis of FDA's new drug development process available today. I recommend this well-written book for professionals engaged in the drug development and review process. --Biopharm Magazine

Customer Reviews

Gray's anatomy for regulatory affairs
I once was told that in drug development regulatory affairs there wasn't an equivalent to a Gray's anatomy or a Goodman & Gilman's pharmacology textbook. Thus I had to jump right into the maze of FDA guidelines and the code of federal regulations (CFR). After I discovered and read the first few chapters of this book I went back to the experienced regulatory affairs person that told me that there wasn't such a textbook and said "here is Gray's anatomy for regulatory affairs!" Indeed, the book covers all regulatory aspects of drug development providing an extensive and clear description of all the regulatory requirements for each phase as well as providing an objective interpretation of the laws. What I most like about this book is that it is self-sufficient in that it summarizes and pulls the relevant guidances and regulations together for each phase in such a manner that the text flows easily and one does not have to stop reading it to look for the original guidance or CFR text. Even a copy of the relevant forms is included in each chapter (for instance form 1571 in the chapter about the IND) so that one can better follow the author's discussion about it. This self-sufficiency seems to be a major advantage of this book because in other regulatory manuals the norm seems to have a text full of links or advices to read the guidance before proceeding to the next sentence of the book which is annoying and many times unfeasible if you don't have immediate access to the myriad of FDA issued documents. Another good thing is that the author also provides down-to-earth but very important information such as who is the present director of a division, why did he/she achieved that position, who was the previous director, where/he she is right now. Overall it is the best textbook I've seen so far in regulatory affairs for prescription drugs.

A fine introductory book, but lacking in depth or examples.
Biologics Development: A Regulatory Overview, by Mark Mathieu is a 330 page book, containing 15 chapters. The paper is a off-white. There are about ten tables and flow charts, and reproductions of two forms, FDA Form 356h and the MedWatch form. This is a review of the second edition (but the currently available edition is still very short, around 350 pages).

Overall, the book is a walk-through that takes us along various rules in Title 21 of the CFR. The book is useful, in that it teaches a pharma or biotech employee things that management might not have time to teach. This book fills a niche, in that other books on clinical trials generally fail to disclose back and forth communications between the sponsor and FDA. But for the price charged for this book, the book does not go far enough. It is only an overview or introduction.

We learn that CBER has an office called OCTMA that provides guidance on how to go about filing an IND. We learn that the IND must be submitted using Form 1571, and that INDs include the Investigator's Brochure and Clinical Study Protocol (pages 64-66) to be used in the Phase I study, and that the CSP must be accompanied with the Consent Form. We learn that Institutional Review Board (IRB) approval is not needed for submitting an IND, but IRB approval is required before carrying out the actual study.

We learn that the Chemistry, Manufacturing, and Control Data (CMC) part of the IND includes drug substance, drug product, placebo (page 67), labels, and environmental analysis requirements sections, and that the Pharmacology & Toxicology Data section includes animal studies, in vitro studies, previous human experience, studies.

After an IND is approved, we learn that subsequent submissions include a revised IB, amendments to the CSP, information amendments, and IND safety reports (these report only AEs that are serious and unexpected, and must be submitted within 10 days after the sponsor's receipt (page 75).

Attention is devoted to the Clinical Hold and partial clinical hold (pages 72, 95, 99, 100, 105), to Informed Consent forms (pages 61, 145, 152-155), and to the label for the drug container and package insert (pages 170-172, 208, 223, 226, 280).

We learn how CBER is organized--its offices include Therapeutics (cytokines, cellular & gene therapies, hematologics, monoclonals), Vaccines, Blood Products, Office of Establishment Licensing & Product Surveillance, Office of Compliance, Office of Communication, and Office of Management. We learn about the time-line followed after submitting the IND, where the decision tree is to proceed (occurs automatically at 30 days after receipt of IND), to call the sponsor about minor deficiencies, or to impose a clinical hold.

An overview is provided of Phase I, Phase II, Phase III, and Phase IV clinical trials (page 107), and we learn about Expedited Development and Accelerated Approval. We are provided with a number of other concepts, but these are only named, and there are no examples (comparison group, multicenter trials, randomization, blinding, Data Safety Monitoring Committee, Endpoints and Surrogate Endpoints). It would have been nice to be provided with a disclosure of how these things are handled differently in oncology versus infectious diseases, but we're left in the dark.

We learn of the responsibilities of the Sponsor (selects investigators, ensures monitoring of trials, to ensure that requirements set forth by IRB and by Consent Forms are followed (page 145), to ensure that investigators understand the IB (page 145).

After the IND is filed, and after the clinical study is completed, a subsequent step is licensing. We are provided with the history of biologics approval, at least as it applies to licensing. We learn that the Establishment License Application (ELA) was implemented early (in 1902), because it was easy to monitor and control manufacturing steps, but that Product Licensing Application (PLA) came much later (in 1944), because it was not until this time that analytical methods became good enough to do quality control on the biologics product. We learn that in 1996, CBER combined the PLA and ELA, where the combination was called, BLA (BLA applies only to plasmids, peptides of 40 or fewer amino acids, monoclonals, and somatic cell therapy) (page 160, 233)

Examples and case histories would be a welcome addition to this book. For example, I would have liked to see a reproduction of a Consent Form, an example of a Synopsis from a Clinical Study Protocol, an example of an FDA Form 483 Warning Letter, a time-line of all milestone documents that are sent to the FDA with commentary disclosing what event triggers the submission of each of these documents, and information of additional FDA documents. I would like to see examples of an Information Request letter and an Advice letter (page 100). We are told of these letters but have no idea of their content.

We are told about INDs, BLAs, PLAs, ELAs, and CSPs, but certainly there are other major documents. Perhaps the following documents were not available at the time of the edition of the book being reviewed, but at the present time (2009), these other documents include a Fast Track Application, a Briefing Document, Statistical Analysis Plan, Change Control Form, and Special Protocol Assessment (SPA).

What is also missing is information about the European equivalent of the FDA, that is, European Medicines Agency (EMEA). I would have also liked to see two or three case histories, for example, disclosing conversations occurring during a pre-IND meeting. An excellent example of cases histories can be found in Data Monitoring in Clinical Trials: A Case Studies Approach by DeMets, et al. In my opinion, the DeMets book is a glorious, no holds barred, well-written treatise, on one aspect of clinical trials (data and safety monitoring committees). If Mark Mathieu's book was less expensive (in the range of $30-$40) it might deserve five stars.

Regulatory Affairs Textbook Standard
The book is a comprehensive collection of Regulatory Affairs information. The book lacks an index. Thankfully, the table of contents is detailed enough to find most of the information one might be looking for.