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This article describes the first-ever patient advocacy group draft guidance to FDA on any disease, focusing on Muscular Dystrophy and potential ways to improve chances of development success for new therapies.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

In a New York Times editorial several years ago, William Safire wrote an essay entitled, "Why Die?"1 According to the writer, nothing makes the weak strong or the fearful brave as much as the body's innate drive to stay alive. His point was that the genetic clock is set to run no more than 120 years, although many people would like to live much longer. A government report summarized the will to survive, noting that the inevitability of aging and the specter of dying have always haunted human life, and the desire to overcome age has long been a human dream.2

Categories: Tags: Science and Technology, life expectancy, polypill, cardiovascular, patients, disease
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
The Ethics of Regulatory Mandates for Pediatric Research

While the efficacy of pediatric research regulations in the US and EU can be debated, ancillary ethical issues have arisen that need to be addressed.

Categories: Tags:
Nanomedicine: Prospects, Risks and Regulatory Issues

Doxil, Ontak and Abraxane are all US Food and Drug Administration (FDA) approved nanoparticle (NP) drug delivery systems for cancer indications. The dynamic development of cancer nanotechnology is in line with the position of the National Cancer Institute (NCI), which has recognized nanotechnology as an unprecedented opportunity to study normal and cancer cells in real time at the molecular scale and during the earliest stage of cancer progression. In the last few years, nanotechnologies have been intensively developed for clinical laboratory analysis, imaging and therapeutics. Although there are exciting prospects for the application of nanomaterials in medicine, concerns over adverse and unanticipated effects on human health have been raised.

Categories: Features Tags: targeting, drug delivery, nanomaterials, delivery, nanotechnology, NPS, cells, cancer, drug
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
The Regulatory Interview: Preparing for Success

This view of the regulatory affairs interview process from the other side of the table provides general tips on preparing for an interview as well as specifics for the dynamic and challenging regulatory profession.

Categories: Tags: interview, regulatory
Data Integrity in the FDA-Regulated Laboratory

Categories: Features Tags: FDA Inspections, 21 CFR 11, Data Integrity, Ranbaxy
The Future of the Regulatory Profession–A Highly Educated Talent Pool

In this article, author Sylva Krizan discusses obtaining an advanced degree before beginning a career in regulatory affairs, and in particular advanced degrees in regulatory affairs.

Categories: US, FDA Tags:
FDA’s Botanical Drug Policy Continues to Develop

As recently as 150 years ago, most pharmaceuticals were obtained directly from plants; now, most are synthetic. However, in the past 20 years, the US Food and Drug Administration (FDA) has seen a future for botanical drug products.

Categories: Features, US, FDA Tags: Regulation of Botanicals, Botanicals, guidance
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