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Showing 1 – 25  of 25

The Life and Times of a Promotional Claims Compendium By Rebecca Rivera Torres, MS, RD, CSSD - Published 30 October 2017

This article discusses developing a "promotional claims compendium" to review pharmaceutical marketing materials. It highlights the advantages of using a compendium for a variety of purposes and the potential value it could bring to not only the review team, but the entire organization.

Categories: Features, US, FDA, Advertising and Promotion, Communication, Drugs

Tags: Promotional Materials, Promotional Claims, Brand Book

RAPS Publishes 10th Edition of Fundamentals of US Regulatory Affairs, Plus Sector-Specific Books on Medical Devices, Biopharmaceuticals By Zachary Brousseau - Published 16 August 2017

RAPS has published the updated, 10th edition of Fundamentals of US Regulatory Affairs, the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: regulatory affairs, text, book, Fundamentals of Regulatory Affairs

Thailand's Approach to Drug Quality Assurance: Creation of the Green Book By Thanita Patthamajinda, RPh - Published 27 April 2017

This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines.

Categories: Features, Asia, Drugs, Quality

Tags: Thailand, Green Book, Quality Assurance

Final FDA Rule Clarifies Pharma Patent Process With Aim of Reducing Unnecessary Litigation By Zachary Brennan - Published 05 October 2016

With the intent to cut back on the types of litigation that can delay the approval and marketing of generic drugs under 505(b)(2) applications and abbreviated new drug applications (ANDAs), the US Food and Drug Administration (FDA) on Wednesday released a final rule that revises and clarifies its regulations on a number of different parts of the pharmaceutical patent process.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drugs, ANDA approval, Orange Book, paragraph IV certifications

FDA Offers First Major Update to ‘Orange Book’ Website By Zachary Brennan - Published 15 August 2016

The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.”

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Orange Book, list of generic drugs from FDA, FDA list of drugs

Updated: RAPS Seeks Authors for International Fundamentals of Regulatory Affairs Book By RAPS Staff - Published 05 May 2016

RAPS will be publishing the third edition of Fundamentals of International Regulatory Affairs later this year. We are looking for authors for chapters on general information, pharmaceuticals, biologics and other product types .

Categories: HTML, Articles, Under RAPS, RAPS

Tags: Fundamentals of International Regulatory Affairs, book, authors

RAPS Seeks Authors for Regulatory Writing Book By RAPS Staff - Published 25 February 2016

RAPS is planning to publish a regulatory writing handbook later this year and is seeking contributing authors.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: regulatory writing, book, authors, call for authors

New Fundamentals of US Regulatory Affairs Book Now Available By Zachary Brousseau - Published 10 August 2015

The updated, ninth edition of Fundamentals of US Regulatory Affairs is now available. The book has been completely updated, and includes extensive, current regulatory information for pharmaceuticals, medical devices and biologics, and covers regulatory topics ranging from the history of food, drug and cosmetic laws to crisis management and FDA inspection and enforcement.

Categories: HTML, Articles, Under RAPS, US, DOJ, FDA, FTC

Tags: Fundamentals of US Regulatory Affairs, ninth editin, 9th edition, US Fundamentals, book, regulatory affairs reference

Book Excerpt: The Medical Device Validation Handbook, Chapter 1: Introduction and History By Max Sherman - Published 16 April 2015

RAPS' Medical Device Validation Handbook, edited by Max Sherman, provides a unique compilation of expert thought and analysis of the validation and verification processes for medical devices. The book examines multiple aspects of validation, including process, design, software, equipment and cleaning validation.

Categories: HTML, Articles, Books, Under RAPS, RAPS, Compliance, Medical Devices, Quality

Tags: medical device, medical devices, medical device validation, validation, medical device process validation, verification, Sherman, book, publication

Regulatory Professionals Need Better Understanding of Medical Device Validation By Zachary Brousseau - Published 16 April 2015

Author Max Sherman says regulatory professionals need a better understanding of medical device validation, and he hopes The Medical Device Validation Handbook fills a void for those who have been waiting for a comprehensive resource on the topic.

Categories: HTML, Articles, Books, Under RAPS, RAPS, Compliance, Medical Devices, Quality

Tags: medical device, medical devices, medical device validation, validation, medical device process validation, verification, Sherman, book publication

Inadequate Medical Device Validation a Common Problem; RAPS Publishes 'How-to' Resource By Zachary Brousseau - Published 16 April 2015

RAPS' Medical Device Validation Handbook, edited by Max Sherman, provides a unique compilation of expert thought and analysis of the validation and verification processes for medical devices. The book examines multiple aspects of validation, including process, design, software, equipment and cleaning validation.

Categories: HTML, Articles, Books, Under RAPS, RAPS, Compliance, Medical Devices, Quality

Tags: medical device, medical devices, medical device validation, validation, medical device process validation, verification, Sherman, book publication

Zarxio, First Biosimilar Approved in the US, Added to FDA's New 'Purple Book' By Alexander Gaffney, RAC - Published 16 April 2015

Slowly but surely, the US Food and Drug Administration (FDA) is making quiet but substantial updates to its new "Purple Book"— a list meant to describe the degree to which a biosimilar drug is equivalent to the biologic product it references.

Categories: News, US, CBER, CDER, Biologics and biotechnology

Tags: Purple Book, Zarxio, Biosimilar, Interchangeable

Second Generic Version of ADHD Drug Concerta Found to Have Problems By Alexander Gaffney, RAC - Published 14 November 2014

US regulatory officials say they have identified not one but two supposed generic copies of the attention deficit hyperactive disorder (ADHD) treatment drug Concerta that have failed to demonstrate required levels of equivalency.

Categories: News, US, CDER, Generic drugs, Postmarket surveillance

Tags: Concerta, Generic, Orange Book, Therapeutic Equivalence, methylphenidate hydrochloride, Kudco

FDA Says it Discovered Problems With Generic Version of ADHD Drug Concerta By Alexander Gaffney, RAC - Published 13 November 2014

A generic attention deficit hyperactive disorder (ADHD) drug manufactured by Mallinckrodt has been found by the US Food and Drug Administration (FDA) to not be sufficiently equivalent to its reference drug, Concerta.

Categories: News, US, CDER, Generic drugs, Postmarket surveillance

Tags: Concerta, Bioequivalence, Therapeutic Equivalence, RLD, ANDA, Orange Book

FDA Considers New Approach Toward Regulation of Dietary Supplements By Alexander Gaffney, RAC - Published 31 October 2014

When you think of the word "book," chances are good it conjures of images of libraries and well-worn tomes. But at the US Food and Drug Administration (FDA), the word is more often associated with several databases used to keep track of critical information about the products regulated by the agency. Now proposed changes to FDA's food-focused Red Book could have implications for the dietary supplement industry.

Categories: News, US, FDA, Nutritional and dietary supplements

Tags: Red Book, Guidance, Toxicology, Food Safety

In Major Move on Biosimilar Interchangeability, FDA Establishes New 'Purple Book' By Alexander Gaffney, RAC - Published 09 September 2014

In a landmark move, the US Food and Drug Administration (FDA) has published its first-ever edition of the "Purple Book," a new list of licensed biological products and interchangeable biosimilars that is meant to be the biological equivalent of the pharmaceutical "Orange Book."

Categories: News, US, CBER, CDER, Biologics and biotechnology, Labeling, Regulatory strategy

Tags: Purple Book, Orange Book, Biosimilarity, Biosimilar, Biosimilars, Interchangeability, Biosimilar Interchangeability

RAPS Seeks Authors for Global Device Strategy Book By Pam Jones, senior publications editor - Published 27 March 2014

RAPS is seeking professionals with multinational experience with medical devices, throughout the lifecycle to authoring chapters for a new publication, Global Strategy for Medical Devices.

Categories: Medical Devices, Under RAPS

Tags: call for authors, Publication, strategy, book, global, regulatory

FDA Proposes Changes to Make Disclosure of Animal Drug Information Less Convoluted By Alexander Gaffney, RAC - Published 14 March 2014

Categories: US, FDA

Tags: Green Book, Direct Final Rule, Federal Register, NADA, CVM, Transparency, Final Rule, Latest News, regulation

J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk By Alexander Gaffney, RAC - Published 05 March 2014

Categories: US, FDA

Tags: Sun Pharma, Orange Book, Janssen, J&J, Lipodox, Doxil, RLD, ANDA, Citizen Petition, Latest News, NDA

Purdue's NDA for Oxycontin Formally Withdrawn as FDA Closes Route to Generic Competitors By Alexander Gaffney, RF News Editor - Published 06 August 2013

Categories: US, FDA

Tags: e Oxycontin, Orange Book, Withdrawal, Purdue Pharma, Latest News

Book Review: Targeted Regulatory Writing Techniques By Meredith Brown-Tuttle, RAC - Published 24 June 2013

Medical writing and regulatory greatly rely on and closely relate to each other. It often is hard to enter either field expecting to be trained on "the basics," since those vary by company, corporate culture, opportunities to learn and co-workers' experience and willingness to mentor. Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics by Linda Fossati Wood and Mary Anne Foote is a wonderful "proxy" mentor that covers the basics I wanted to know when I first entered the regulatory field.

Categories: Medical writing

Tags: book

Have Efforts to Relax Regulatory Requirements Been Antithetical to Industry's Aims? By Alexander Gaffney, RF News Editor - Published 08 April 2013

Categories: US, FDA

Tags: Drug Lag, book, regulation

FDA Publishes 33rd Edition of Orange Book By Alexander Gaffney, RF News Editor - Published 21 February 2013

Tags: 2013 Orange Book, Orange Book

Orange Book Listings Lesson: An overly broad use code may lead to legal challenges By Jane Wright-Mitchell, PharmD, JD - Published 23 July 2012

The US Supreme Court's recent Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S decision highlights the different viewpoints of the courts in the pharmaceutical arena, in particular drawing attention to the interaction of pharmaceutical patents to the US Food and Drug Administration (FDA)-generated Orange Book.

Categories: FDA

Tags: Caraco Pharmaceuticals, Orange Book, Novo Nordisk, Court, SCOTUS, ANDA, It's the Law, decision, legal

A Conversation With From Alzheimer's to Zebrafish Author Max Sherman By Zachary Brousseau - Published 30 March 2012

Pharmacist and seasoned regulatory professional Max Sherman has written on science and medical topics for years, and began writing for RAPS' magazine Regulatory Affairs Focus, as it was called at the time, more than a decade ago. Over the years, his writing has covered a range of diverse and occasionally unusual subjects related to the practice of medicine, medical research, regulatory issues, biology, chemistry and other related disciplines. He has taught university-level classes on quality and regulatory affairs, and his writing is often educational, whether it's a history lesson about quack medical devices, a biology lesson about bats or a peek into processes of the US Food and Drug Administration (FDA), it's almost impossible not to learn something new reading one of Sherman's articles. At the same time, he writes in an accessible and entertaining style. RAPS has now published a collection of Sherman's articles from Regulatory Focus and other publications, entitled From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories. I recently had a chance to talk with him about the book and his writing. Following is an edited transcript of our conversation.

Categories: Under RAPS

Tags: Interesting, Sherman, Science, Animal, Bug, Insect, medicines, interview, book, disease, regulatory