Featured Articles

In-depth examination and analysis of regulatory and related topics, available exclusively to RAPS members.

Tumor Paint—A Novel Approach to Enhance Surgical Resection

An experimental imaging agent dubbed "tumor paint" could help surgeons resect tumors with the least amount of damage to surrounding healthy tissues. The tumor paint is being studied in gliomas, among the deadliest forms of cancer.

Categories: In vitro diagnostics, Research and development, Features, FDA Tags:
Asia Regulatory Roundup: Status Quo for Indian Trials; TGA Inspections Lag (11 November 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein. This week's top news includes Australia's struggle to inspect foreign and domestic drug manufacturing facilities and India's about-face on a reported clinical trials proposal.

Categories: Regulatory intelligence, News, China, India, Oceania, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
European Regulatory Roundup: EMA, FDA Clash Over Ebola Approaches (6 November 2014)

Welcome to our European Regulatory Roundup, a new feature exclusively for RAPS members. This week's edition covers the EMA's approach to regulating experimental Ebola treatments, EMA's new draft guideline on influenza vaccine development, new efforts to harmonize HTA approaches, and more.

Categories: Regulatory intelligence, News, EMA, MHRA, NICE Tags: European Regulatory Roundup, Regulatory Roundup, EU Regulatory Roundup
21 CFR Part 11: The Ins and Outs of One of FDA's Most Difficult Rules

1992 was a different time, when the Internet was still in its infancy and email as a corporate tool was only just beginning to take hold. In the life science industry, there were dreams—then unrealized—of a completely electronic and totally paperless office. And at the US Food and Drug Administration (FDA), regulators were only just beginning to realize the potential effects digital data management systems could have on product development.

Categories: Clinical, Regulatory intelligence, Features, US, FDA Tags: 21 CFR Part 11, 21 CFR 11, Electronic Data, Electronic Recordkeeping, Electronic Records
Asia Regulatory Roundup: China's Biosimilar Guidelines Revealed (4 November 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein. This week's edition features news on China's new biosimilar guidelines, clinical trial updates in India, China's crackdown on marketers of fraudulent pharmaceuticals, and India's peculiar finding about fake drugs.

Categories: Regulatory intelligence, News, China, India, Oceania Tags: Asia Regulatory Roundup, Regulatory Roundup
Central Africa: Defining a Regulatory Strategy for the Region

  Central Africa presents a number of regulatory challenges to drug manufacturers, beginning with the complexity of dealing with the network of many local and international organizations that provide a framework for drug regulation. This article examines harmonization policies, defining a regulatory submissions strategy and determinants of regulatory success in Central Africa and provides a contact list for the 12 countries that make up the region.  

Categories: Drugs, Regulatory strategy, Submission and registration, Features, Africa, FDA, ICH, WHO Tags:
European Regulatory Roundup: Confusion Remains Over EU Device Oversight (30 October 2014)

Welcome to our European Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting the EU and the companies operating therein. This week's edition features information on an important medical device question in the EU, EMA's efforts to spur development of Ebola treatments, and a new and important change in the regulation of biosimilars.

Categories: Regulatory intelligence, News, Europe, EMA, EC Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
Asia Regulatory Roundup: India to Accredit Trials in 2015; Singapore Considers Regulatory Overhaul (28 October 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein. This edition's top stories include India's efforts to accredit more clinical trials, Singapore's attempt to simplify the regulation of pharmaceuticals, and Australia and India's drives toward regulatory efficiency.

Categories: Regulatory intelligence, India, Oceania Tags: Asia Regulatory Roundup, Regulatory Roundup
Two Extraordinary Medical Writers: Lewis Thomas and Sherwin Nuland

Good medical or scientific writing is an integral requirement for regulatory and clinical research professionals. The author presents thoughts on the works of two great practitioners of the craft: Lewis Thomas and Sherwin Nuland.

Categories: Medical writing, Features, Communication Tags: medical writing
China's Regulatory Procedure and Inspection System

Current information on the China Food and Drug Administration regulatory authorities and its inspection systems, including the role of Provincial and City FDAs.

Categories: Active pharmaceutical ingredients, Prescription drugs, Features, China, CFDA, APIs Tags: CFDA, regulatory authorities, Provincial FDA, City FDA, inspection processes
European Regulatory Roundup: Drug and Device Oversight to Stay Under DG Sanco (23 October 2014)

Welcome to our European Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting the EU and the companies operating therein. This week's edition includes stories on a cancelled plan to move oversight of healthcare products to a new committee, EFPIA's opposition to clinical trial labeling rules, EMA's efforts to combat Ebola, and the UK's move to allow unlicensed drugs for terminally ill patients.

Categories: Regulatory intelligence, News, Europe, EMA, EC, MHRA, NICE Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
Asia Regulatory Roundup: India's Effort to Clean up its Regulatory Reputation (22 October 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein.

Categories: Regulatory intelligence, News, Asia Tags: Asia Regulatory Roundup, Regulatory Roundup
West Africa: Defining a Regulatory Strategy for the Region

Determining a regulatory strategy for a specific West African country requires assessment of infrastructure, resources and sponsor-agency relationships to achieve the best results. This article addresses the challenges of registering products in West Africa and describes different agencies involved in the regulatory process while giving an overview of harmonization efforts.

Categories: Drugs, Submission and registration, Features, Africa, EMA, ICH, WHO Tags:
European Regulatory Roundup: Head of DG Sanco Resigns, EMA Publishes Info on Trials Database (16 October 2014)

Welcome to our European Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting the EU and the companies operating therein.

Categories: Regulatory intelligence, News, Europe Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup
Asia Regulatory Roundup: Packaging Problems in India, China Confronts Ebola (15 October 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein.

Categories: Regulatory intelligence, News, Asia Tags: Asia Regulatory Roundup, Regulatory Roundup
Data Integrity Déjà Vu

Data integrity issues have been observed in R&D, manufacturing, marketing and regulatory departments as well as in the failure to maintain raw data or support CGMPS. This articles outlines how companies can prepare for inspections covering data integrity, provides recent examples of data integrity violations and recaps some of the data integrity issues from the 1980s that led to the generic drug scandal.

Categories: Active pharmaceutical ingredients, Prescription drugs, Generic drugs, Compliance, Ethics, Manufacturing, Quality, Features, US, FDA, EMA, MHRA Tags:
European Regulatory Roundup: EMA's Mid-Year Report Shows Progress (9 October 2014)

Welcome to our European Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting the EU and the companies operating therein.

Categories: Regulatory intelligence, Europe Tags: EU Regulatory Roundup, Regulatory Roundup
Easily Avoidable MDR Mistakes

A comprehensive and cost-effective approach to meeting FDA’s Medical Device Reporting (MDR) requirements should be based on all available FDA resources, and the procedures implemented should avoid common mistakes. Companies sometimes face enforcement action when they miss a commonly overlooked MDR requirement or fail to prepare a document in accordance with FDA preferences.

Categories: Medical Devices, Compliance, Regulatory strategy, Submission and registration, Features, US, FDA Tags:
Asia Regulatory Roundup: Reaction to India's New Device Rule Mixed (8 October 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein.

Categories: Regulatory intelligence, News, Asia Tags: Asia Regulatory Roundup, Regulatory Roundup
Developing a Regulatory Strategy for East and Southern Africa

Developing a regional African regulatory strategy requires making an early determination of the key markets that will be targeted based on the size of country vs. medical need, time to approval, competition, language, etc. This article addresses East and Southern Africa, as they are major markets that often follow European initiatives.

Categories: Drugs, Distribution, Features, Africa, WHO Tags:
European Regulatory Roundup: Patients to be Included in Regulatory Process (2 October 2014)

Welcome to our European Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting the EU and the companies operating therein.

Categories: Regulatory intelligence, News, Europe, EMA Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup
Asia Regulatory Roundup: India's New Drug and Device Labeling Laws (2 October 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein.

Categories: Regulatory intelligence, Asia Tags: Asia Regulatory Roundup, Regulatory Roundup
China’s New Medical Devices Importation Regulations: An Overview

The China Food and Drug Administration (CFDA) issued new regulations for the importation into the country of Class II and Class III medical devices and in vitro diagnostics (IVDs). Administrative Order No. 208 took effect 1 October 2014 and is detailed here.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, Features, China, CFDA Tags:
Mapping Safe Harbor for Off-Label Communications

The debate between drug companies and the US government over off-label promotion and First Amendment rights has been highlighted in a recent case involving the dissemination of off-label reprints. This article discusses the arguments made on both sides and reviews the evolution of FDA reprint guidance documents issued over the last few years as they relate to communicating off-label information to healthcare providers.

Categories: Drugs, Medical Devices, Compliance, Distribution, Postmarket surveillance, Features, US, FDA, DOJ Tags:
European Regulatory Roundup: Regulation of Pediatric Products Lacking (25 September 2014)

Welcome to our European Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting the EU and the companies operating therein.

Categories: Regulatory intelligence, News, Europe, EMA Tags: EU Regulatory Roundup, Regulatory Roundup
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