Featured Articles

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

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
DTC Broadcast Advertisements: The Evolution of Major Statements

Direct-to-consumer (“DTC”) advertising has a long, robust regulatory history, mostly rooted in debates over the pros and cons of promoting a prescription drug directly to consumers. This article focuses on how the pharmaceutical industry communicates risk information in what can arguably be considered the most prominent and industry-preferred medium for healthcare advertising to consumers—broadcast advertising.

Categories: Drugs, Compliance, Postmarket surveillance, Features, US Tags: direct-to-consumer advertising, history, FDAAA, enforcement actions
Asia Regulatory Roundup: India Mulls Drug, Device Changes (24 September 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: Regulatory Roundup, Asia Regulatory Roundup
Medical Device Regulatory Update: Usability, UDI and RoHS

Human factors engineering (HFE), unique device identifiers (UDIs) and restriction of hazardous substances (RoHS) have more in common than one might think. At the recent 2014 RAPS San Francisco Bay Area Chapter’s annual educational conference, attendees gathered to enhance their understanding of HFE, the requirements for UDI and the impact of the RoHS 2 Directive 2011/65/EU1 aimed at devices currently under Directive 93/42/EEC (MDD) and 90/385/EEC (IVD).

Categories: Drugs, In vitro diagnostics, Medical Devices, Compliance, Manufacturing, Packaging, Features, US, Europe Tags: Human Factors Engineering, HFE, usability engineering, Unique Device Identifiers, UDI, medical electronics, RoHS, restriction of hazardous substances, FDA, EU, directives
Leprosy––Not Yet Consigned to History

Leprosy has so far eluded efforts to find the final piece of information that might eradicate the age-old disease permanently. Max Sherman writes on the history of leprosy, its etiology and clinical types, treatment and next steps.

Categories: Prescription drugs, Research and development, Features Tags: Leprosy, skin diseases, etiology, current treatment, new approaches, NIH, NIAID
European Regulatory Roundup: Shift in Pharmaceutical Regulation Criticized (18 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, EC, MHRA Tags: EU Regulatory Roundup, Regulatory Roundup
Orphan Drugs Around the World: The Regulations and Requirements You Need to Know

"Orphan drugs" are product intended for use in the treatment of a "rare" disease—those diseases that occur infrequently or rarely in the general population of a specific location. 

Categories: Biologics and biotechnology, Drugs, Features, US, Canada, Europe, Asia, Latin America and Caribbean, Middle East, Oceania, FDA, EMA, EC, PMDA, TGA Tags: Orphan Drugs, Orphan Disease, Orphan Drug Act, Ultra-Orphan Diseases, Orphan Drug Regulations
Asia Regulatory Roundup: India's Quality Control Problems, Japan Questions Drug Risks (16 September 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, Japan, China, India, PMDA, CFDA, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
Developing Compliant Search Engine Marketing Campaigns

An overview of FDA’s 2009 enforcement actions for violations related to paid search engine marketing (SEM) and lessons learned combined with subsequent developments for creating a framework for using SEM compliantly, including areas where FDA guidance is still unavailable or unclear.

Categories: Prescription drugs, Generic drugs, Medical Devices, Labeling, Features, FDA Tags:
European Regulatory Roundup: Veterinary Changes, Calls for Device Reforms (11 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, Features, Europe Tags: Regulatory Roundup, EU Regulatory Roundup
Asia Regulatory Roundup: Big Changes for Clinical Trial Regulations (8 September 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, Features, Asia Tags: Asia Regulatory Roundup
European Regulatory Roundup: EU Mobile Apps Framework, Pharmacovigilance Changes (8 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, Features, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup
« 1 2 3 4 5  ... »