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This article describes the first-ever patient advocacy group draft guidance to FDA on any disease, focusing on Muscular Dystrophy and potential ways to improve chances of development success for new therapies.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

The mechanism of hearing loss is a subject with which we aging individuals should be acquainted. This article is a follow up to my previous publication pertaining to the sense of smell, and it very briefly describes the anatomy of the ear; the complicated biomechanics of sound; and the prevalence and causes of hearing loss.

Categories: Tags: Ear, Hearing
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
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
New Regulations for Medical Devices in China: Clinical Trials and Beyond

The China Food and Drug Administration (CFDA) has been actively expanding and updating its regulatory process for medical devices, including its 2013 Medical Device Supervision and Regulation.

Categories: China, CFDA Tags:
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
New FDA Draft Guidance on Device Recalls and Product Enhancements: Does It Muddy the Water for Manufacturers?

Draft guidance issued by FDA on 22 February 2013 describes the agency's thought process for distinguishing between product recalls and product enhancements and their associated reporting requirements. This new draft guidance document may raise new questions about reporting requirements and leave some regulatory loopholes that need to be addressed.

Categories: US, FDA Tags: guidance, medical device
Communicating Important Drug Safety Messages: the Dear Health Care Provider Letter

During a prescription drug's lifecycle, new safety information frequently emerges that may affect its benefit:risk profile in some patients and require changes in the product labeling. One mechanism used by pharmaceutical sponsors to promptly communicate new drug information to US prescribers is the "Dear Health Care Provider" (DHCP) letter.

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
Anesthetics: Questions Still Abound

This article attempts to answer questions about anesthetic drugs -- their mechanism of action, their qualities and their side effects -- while providing an abbreviated history of anesthesia.

Categories: Tags: pharmaceutical, drug
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