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This article describes the first-ever patient advocacy group draft guidance to FDA on any disease, focusing on Muscular Dystrophy and potential ways to improve chances of development success for new therapies.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

Life science organizations today are faced with increasing regulatory pressure to offer products that are compliant, effective and efficient. While this is certainly the goal for many companies, issues often arise along the way, whether through a non-conformance identification, audit finding, customer complaint or another quality event. This is where root-cause analysis can help. While many people anxiously await the next miracle problem-solving tool, let me suggest an old and reliable friend-the fishbone diagram.

Categories: Tags:
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
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
HCEI: Is Industry any Closer to a Clear Definition of Adequate Evidence?

Sixteen years after the passage of FDAMA, one section of the law is still a subject of much debate within the industry: Section 114, which outlines the standard of evidence the pharmaceutical industry must meet to promote healthcare economic information (HCEI).

Categories: Tags: FDAMA
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
Investment Decisions Based on Biosimilar Programs, Part 2

This article is the second part of a two-part series examining the environment for third-party capital providers interested in investing in biosimilars. It describes three hurdles facing potential investors: access to capital, exclusivity and intellectual property and commercialization.

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
Coverage of IDE Clinical Trial Costs: Navigating the Medicare Maze

Regulatory professionals recognize the value of clinical research in the medical device development process. The reward of obtaining third-party insurance coverage during a clinical trial is significant, but seeking such coverage by third-party payers has proven complex and confusing even for the most seasoned of professional teams. That is exactly why multinational corporations looking to study medical technologies, and even those small- and mid-cap companies undergoing recent financing challenges have in the past hired reimbursement consultants to help them navigate this third-party payer maze.

Categories: Clinical, Features Tags: pre-determination, services, navigating, costs, IDE, Medicare, trial, clinical trial
« 1 2 3 4 5  ... »