Featured Articles

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

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
What’s In a Name? The Value of Pharmaceutical & Biologic Branding

The Hatch-Waxman Amendments are 30 years’ old this month and introduced generics as we know them. Its milestone anniversary, combined with FDA’s recent release of its Draft Guidance on Best Practices in Developing Proprietary Names for Drugs, drives the authors to ask: When it comes to innovative drug products, what’s in a name?

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Over the counter drugs, Features, US, FDA Tags: Hatch-Waxman Amendments, proprietary drug names, look-alike/sound-alike drugs, draft guidance, best practices
Core Competencies Provide Roadmap for Strengthening Regulatory Education

The Association of Graduate Regulatory Educators (AGRE) describes a set of core competencies for a regulatory science curriculum and discusses the relationship between these skills and knowledge and the expectations of potential employers.

Categories: Career Development, Clinical, Compliance, Quality, Regulatory strategy, Features Tags:
Filling a Regulatory Void: Patient Advocates Submit Guidance for Duchenne Muscular Dystrophy

This article describes the first-ever patient advocacy group draft guidance to FDA on any disease, focusing on Muscular Dystrophy and potential ways to improve chances of development success for new therapies.

Categories: Regulatory strategy, News, US, FDA Tags: DMD, Muscular Dystrophy, Guidance, Patients, Patient-Developed Guidance, FDA Guidance, Duchenne Muscular Dystrophy
John Snow—The First Epidemiologist?

Epidemiology studies often play an important role in the approval or postmarketing surveillance of healthcare products. In this article, the author discusses what likely was the first epidemiology study––renowned English physician John Snow’s research into a cholera outbreak in London in 1854.

Categories: Postmarket surveillance, Features Tags: Epidemiology, John Snow, Cholera
Proving a Professional’s Regulatory Worth During Salary Negotiations

Even if a person does not get what is deserved in life, a regulatory professional often has a better chance of getting what is deserved on the job if he or she can negotiate salary effectively. To evaluate worth to an employer, the regulatory professional must know him- or herself, the business ecosystem and his or her ability to deliver desired professional qualifications.

Categories: Business Skills, Features Tags: Salary, Salary Negotiations, Regulatory Affairs Salary, Salary Negotiating Tips
China’s Order 650 and its Impact on Medical Device Regulation

On 31 March 2014, the Chinese government finally released Order 650 (former Order 276), Regulations for the Supervision and Administration of Medical Devices. The order, effective 1 June 2014, sets the fundamental framework and orientation on medical device supervision and administration in China.

Categories: In vitro diagnostics, Medical Devices, Features, China, CFDA Tags: Order 650
East African Community Registers Five Drugs in Pilot Program

The East African Community Medicines Regulatory Harmonization (EAC-MRH) program reached a major milestone this year with the successful registration of five critical health products.

Categories: Drugs, Submission and registration, News, Africa Tags: Africa, EAC, AMRH, MRH, Kenya, Uganda, Burundi, Rwanda, Tanzania, Registration
The Science Behind What You See

No other sense organ is as critically important to the activities of daily living as our eyes. This article, which describes sight and the vision process, is the third in a series the author is writing about the five senses. Articles on hearing and smell were published in Regulatory Focus in 2013. This article briefly discusses eye anatomy, the miracle of vision, the evolution of sight and ocular diseases (cataracts in particular), and provides references for further reading.

Categories: Features Tags: Senses, Max Sherman, Eye, Vision
What Is ‘Regulatory Intelligence’?

The buzz phrase “regulatory intelligence” (RI) is appearing with increasing frequency, but what is it, exactly?

Categories: Regulatory intelligence, Features Tags: Regulatory Intelligence, RI, What is Regulatory Intelligence, Regulatory Intelligence Definition
Considering a Business Presence in Latin America? What You Should Know about Regulatory in the Region

When considering expanding or relocating to Latin America, companies typically focus on business decisions. Should an office be established in each country or should business be done through local distributors? Often, companies neglect to design a specific regulatory strategy, even though regulatory issues are an important element in an effective business plan.

Categories: Regulatory strategy, Submission and registration, Features, Latin America and Caribbean Tags: Brazil, Latin America, Brazil Regulations
Safety Concerns Related to Global Biosimilars Drug Development

An initial unfortunate experience in the late 1990s served as an alert to the inherent risks of making apparently small changes to a biological product. 

Categories: Biologics and biotechnology, Clinical, Postmarket surveillance Tags: Biosimilars, Biosimilarity, Biosimilar Safety, Safety of Biosimilars
Recent Changes to the Regulation of ‘Food-Like’ Natural Health Products in Canada

The Canadian regulatory landscape for foods and natural health products (NHPs), which are roughly equivalent to US dietary supplements, has experienced significant recent change.

Categories: Features, Canada, Health Canada Tags: Canada, Natural Products, NHP, Natural Health Products, Food
Beyond Parity: Lowering Adverse Drug Event Risk through Incentivized Pharmacogenetics

The US Food and Drug Administration (FDA) recently proposed a new rule to address postapproval generic drug labeling. This articles argues that in order to actually lower the risk of these incidents occurring, FDA should instead create a program that incentivizes manufacturers to work with health professionals to perform postapproval pharmacogenetic and pharmcogenomic (PGx) studies in patients who have suffered serious adverse drug reactions (ADRs).

Categories: Generic drugs, Features, US, CDER Tags: PGx, Pharmacogenetics, Pharmacogenomics, Generic Drug Labeling Rule, Generic Drug Labeling, CBE, Pliva v. Mensing, Failure-to-Warn, ADR,
Gaining Market Access in China: The Complex Process of Drug Listing, Bidding, Pricing and Reimbursement

This article focuses on the key CFDA agencies determining drug pricing and reimbursement in China. It provides the knowledge needed to understand China’s pricing system and help maximize a company’s drug’s price.

Categories: Drugs, Reimbursement, Features, China, CFDA Tags:
Itching—a Diabolical, Peculiar and Often Unsolvable Problem

This article briefly describes the neuroscience of itching, causes of chronic and acute itching, nocturnal itching, scratching and current and potential new treatment methods.

Categories: Features Tags: Itching, Scratching, Pruritus
Perspectives on the FDASIA Health IT Report and Public Workshop

On 7 April 2014, a Food and Drug Administration Safety and Innovation Act (FDASIA)-mandated workgroup issued its strategy and regulatory framework document on health IT to Congress.

Categories: Medical Devices, Features, US, FDA Tags: ONC, FDASIA, Health IT, Health IT Working Group, Health IT Workgroup, Health IT Report
Generic Drug-Device Combinations: A Framework for Understanding FDA Approval Requirements

As innovations in drug delivery systems continue to emerge, so do the number of drugs with a device component. These so-called drug-device combinations include many types of products regulated by the US Food and Drug Administration (FDA), such as drugs prepackaged in inhalers and auto-injectors, transdermal patch delivery systems and various types of kits.

Categories: Combination products, Generic drugs, Medical Devices, Features, US, CDER, CDRH Tags: Combination Products, Generic Drugs, Drug Delivery Systems, Drug-Device Combinations
Impact of Clinical Utility Requirements on In Vitro Diagnostic Assays

With the growth of personalized medicine, IVD assays have become part of clinical utility questions when they are used as companion diagnostic assays in conjunction with pharmaceutical or biologic clinical trials. Now, clinical utility questions also are being asked of many standalone IVDs with target populations or higher-risk intended uses such as early diagnosis, prediction or prognosis. In the case of CDx, evidence of the device's clinical utility for the intended purpose (selection of patients with a previously diagnosed condition or predisposition eligible for a targeted therapy) is required. This new view of IVD clinical utility represents a paradigm shift in IVD planning and has an impact on clinical trial design and implementation.

Categories: Features, US, FDA Tags: Clinical Utility, Assays, CDx, Companion Diagnostic, In Vitro Diagnostic, IVD
Usability and Self-Selection Trials – Clinical Studies of Human Factors

Most clinical trials conducted for US Food and Drug Administration (FDA)-regulated medical devices are focused on two key objectives: safety and effectiveness. However, a unique challenge rarely found in the realm of pharmaceuticals exists for a medical device, which is to consider human factors and usability in its design to maintain safety and effectiveness.

Categories: Features Tags: Human Factors, HFT, Human Factors Testing, clinical trials, medical device
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