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This article describes the first-ever patient advocacy group draft guidance to FDA on any disease, focusing on Muscular Dystrophy and potential ways to improve chances of development success for new therapies.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.
Tags: Senses, Max Sherman, Eye, Vision
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,
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.
Tags: Itching, Scratching, Pruritus
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
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
Answering the Call for Excellence in Regulatory Education
The regulatory landscape has evolved dramatically in the last few decades. Today’s regulatory professionals perform key functions in their organizations, including ensuring compliance with regulations and facilitating the development and commercialization of new products. These professionals must be equipped to address the increased complexity of the modern regulatory landscape.
Tags: AGRE, MA in Regulatory Affairs, Master's in Regulatory Affairs, regulatory affairs, Regulatory Affairs Education, Regulatory Affairs Masters Degrees
Creating a Culture of Compliance
In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
Categories: Compliance, Quality, Features
Tags: CAPA, Continuous Improvement, QMS, Quality Management System
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.
Tags: Human Factors, HFT, Human Factors Testing, clinical trials, medical device
Sleep—Still a Mystery!
Most people spend a full third of their lives asleep, yet most of us do not have the faintest idea what sleep does to our bodies and our brains.
Tags: Effects of Sleep, Science of Sleep, Sleep, Science and Technology
Getting the Match Right
Recognizing that consultants are not one-size-fits-all, clients who develop a framework to screen potential consultants before working together enjoy a greater likelihood of success later.
Tags: Regulatory Consultants, Outsourcing in Regulatory, Regulatory Outsourcing, Regulatory Contracting, Outsourcing, Perspective
Legal Considerations When Outsourcing: Hold on Loosely, but Don’t Let Go
In 1981, the US rock band .38 Special sang "Hold on Loosely, But Don't Let Go." This song lyric about love also holds true when considering whether to outsource regulatory responsibilities.
Tags: Risks of Regulatory Outsourcing, Outsourcing in Regulatory, Regulatory Outsourcing, Outsourcing
Debarred, Denied, Restricted? Legal Responsibilities in Outsourcing
Regulatory professionals frequently work with their supply chain colleagues to ensure all relevant documentation is provided for the export of goods from the country of origin. However, there are little-known US regulatory requirements with potentially significant administrative and criminal consequences for violation, and many manufacturers may not be aware of them.
Tags: Export Restrictions, Department of the Treasury, Department of State, Department of Commerce, Resricted, Outsourcing, Debarred, Denied, Export, Import, It's the Law
Medical Device Industry and Regulator Harmonization Efforts Update
As more countries formalize medical device regulations, international regulatory and quality systems professionals must continually refine and harmonize their internal processes for registration of medical device products and adherence to international quality standards.
Categories: Features, IMDRF, GHTF
Tags: RPS, MDSAP, harmonization, medical device