Featured Articles

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

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This article describes the first-ever patient advocacy group draft guidance to FDA on any disease, focusing on Muscular Dystrophy and potential ways to improve chances of development success for new therapies.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
Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

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 Case for Quality from an Industry Perspective

The US Food and Drug Administration (FDA) recently has asked whether it has been using the right methods to improve device quality. This article is an introduction to the history of quality improvement and its implementation.

Categories: RAPS Events, FDA Tags: History of Quality Improvement, Quality Improvement, Case for Quality, Science and Technology
Mathematics: The Essentials for All Regulatory Professionals

Mathematics underpins everything in medical science, and is a field that all regulatory professionals should embrace. This article offers a brief overview for those looking for an introduction to the field of statistical science and its relation to regulatory affairs.

Categories: Tags: Mathematics, Statistics
Perspectives on FDA Review of Medical Devices: Part I

From genetically modified mosquitoes (to fight malaria), to robotic-based artificial limbs to a surgical cure for hypertension, it seems healthcare innovation is alive and well. But the US Food and Drug Administration (FDA) has been besieged by critics who claim the agency is a hindrance to innovation and a threat to the US med-tech industry. Are they right?

Categories: Technology, FDA Tags: R&D, Approvals, Perspective, innovation, medical device
Seeing the Bigger Audit Picture with an Enterprise Quality Management System

A comprehensive and effective enterprise quality management system (EQMS) allows each audit hierarchy and process to be configured to meet the specific needs and requirements of each unique audit group (GLP, GCP, GMP) while allowing across-the-board analysis.

Categories: Audit Tags: GLP, QMS, GCP, GMP
Transforming Temporary Resourcing into Strategic Resourcing

This article shares some tools for temporary resourcing the authors have leveraged over the years that can be helpful for hiring managers as well as individual contributors.

Categories: Tags: Regulatory Outsourcing, Hiring in Regulatory, Temporary Resourcing, Regulatory Careers, Perspective
Aging: An Amazing Continuous Process

Aging defies an easy definition, at least in biological terms. It is not merely the passage of time. Age is the manifestation of biological events that occur over a span of time. It's also the subject of this Focus article by Max Sherman.

Categories: Tags: Aging, Age
Data Integrity in the FDA-Regulated Laboratory

Categories: Features Tags: FDA Inspections, 21 CFR 11, Data Integrity, Ranbaxy
The Sense of Smell---Dogs or Us?

There was a recent report that researchers in France are working on a sensor to detect explosives carried by individuals who hope to smuggle them through airport security systems. The hope is to create a device that could supplement or even supplant the best mobile bomb detector-a sniffer dog.

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Emerging Pharmaceutical Markets: Industry Challenges

Emerging pharmaceutical markets will account for 30% of global spending in 2016. With growing economies, big patient pools, increasing numbers of patients with chronic diseases and regulatory bodies motivated to bring new medicines to market, these countries could be the oasis that pharmaceutical giants need amid a growing desert of drugs going off-patent and increasing generic competition in mature markets like the US and Europe.

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