Featured Articles

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

Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

An analysis of the impact of FDA’s four expedited programs on development and review of drugs for serious conditions over the last two-and-a-half years since breakthrough therapy designation was introduced, including a performance summary.

Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, US, FDA Tags: Breakthrough therapy designation, fast track designation, priority review, accelerated approval pathway, unmet medical needs
FDA’s Expedited Programs for Serious Conditions: An Overview

An overview of FDA’s four expedited drug development programs for serious or life-threatening conditions: fast track designation, breakthrough therapy designation, priority review designation and the accelerated approval pathway.

Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, US, FDA Tags: Fast track designation, breakthrough therapy, priority review, accelerated approval, serious conditions, life-threatening conditions
Melanoma Treatments: A History of US FDA Approvals

Studying the history of regulatory approvals can provide insights into regulator expectations for new products. Data sets on which US Food and Drug Administration (FDA) approvals for melanoma treatment products were based were examined to determine whether trends have changed in the level of evidence provided.

Categories: Biologics and biotechnology, Drugs, Clinical, Labeling, Postmarket surveillance, Research and development, Features, US, FDA Tags: Melanoma, cancer, malignancies, malignant melanoma, approval history, US FDA approvals
Insights on Japan's 'Sakigake' Regulatory Strategy

A review of Japan’s “Sakigake” (“pioneer”) regulatory strategy, designed to bolster innovation in the biopharmaceutical industry.

Categories: Drugs, Regulatory strategy, Features, Japan Tags:
Expedited Medical Device Submissions in the US: Special 510(k), Abbreviated 510(k), HDE

An overview of expedited pathways for US medical devices that are alternatives to Traditional 510(k)s and Premarket Approval Applications (PMAs). These include Special 510(k), Abbreviated 510(k) and Humanitarian Device Exemption (HDE) submission types.

Categories: Medical Devices, Submission and registration, Features, US, FDA Tags: expedited pathways, Traditional 510(k)s, Special 510(k)s, Abbreviated 510(k)s, Humanitarian Device Exemption, HDE, clearance
Teaching: An Integral Responsibility for Regulatory Professionals

Effective teachers make a significant difference in student achievement. Online courses are no substitute. Interaction with a trainer allows ideas to be exchanged freely and without communication barriers. Qualified teachers help learners make fewer mistakes and, thus, reduce the likelihood of errors in the workplace. Tips on class preparation, presentation, assessment and follow-up for regulatory professionals who must all, at some point, be teachers.

Categories: Features, Business and Leadership, Communication Tags:
Posting Public Comments Can Increase Consumer Engagement with FDA

An argument that timely online posting by the US Food and Drug Administration of all public comments submitted by individual consumers would increase public engagement and align well with other efforts by the agency to facilitate public input about policy issues.

Categories: Features, US, FDA, Communication Tags:
CROs: Selecting and Managing Contract Regulatory Development Resources

CROs have emerged as critical partners in drug development, whether they offer comprehensive or focused services. This partnership requires effective integration of internal and external processes and programs that are managed proactively.

Categories: Drugs, Project management, Features Tags:
Out of Africa: Six Regulatory Articles that Span the Continent

Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southern Africa, West Africa, Central Africa, Northern Africa and South Africa. The articles contain the regulatory agency contacts/responsible parties for countries in each geographic area. The collection also includes an articles on RCOREs.

Categories: Drugs, Government affairs, Project management, Submission and registration, Features, Africa Tags: Africa, South Africa, Northern Africa, North Africa, West Africa, Central Africa, East Africa, Southern Africa, RCOREs, regional centres of excellence, submission, submission and registration, dossier, regulatory submission, regulatory training, regulatory strategy, WHO, NEPAD, East African Community, EAC, regulatory challenges, harmonization, ministry of health, ministere de la sante
Outsourcing Pharmacovigilance in Small Pharmaceutical Companies: A Perspective

A look at the blended approach and other options for an outsourced pharmacovigilance model and their benefits for small pharmaceutical companies. This article provides advice on the steps required to complete a successful PV outsourcing project.

Categories: Drugs, Project management, Features Tags:
Outsourcing: Not My Problem?

The vast majority of outsourcing decisions affect regulatory submissions/applications and pharmacovigilance to varying degrees. Therefore, outsourcing should be of considerable interest to regulatory professionals. By making outsourcing issues their concern, regulatory professionals can ensure it is not a problem.

Categories: Drugs, Project management, Regulatory strategy, Features Tags:
Pharmaceutical Outsourcing: A Korean Perspective

Background on the South Korean pharmaceutical industry and how companies select and choose suppliers and contractors, including regulatory affairs or regulatory compliance consultants or providers.

Categories: Drugs, Regulatory strategy, Features, Korea Tags:
Regulatory Focus Recap: January 2015

A recap of Regulatory Focus feature articles published in January 2015 for your reading convenience.

Categories: Drugs, In vitro diagnostics, Medical writing, Preclinical, Features Tags:
South Africa Medicines Regulatory System Overview

South Africa’s pharmaceutical regulating body, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals. In the last decade, limited resources have meant increased review timelines. To ensure a timely and successful application, it is crucial for pharmaceutical companies to facilitate open discussions and exchange information with key MCC regulators, listed herein.

Categories: Drugs, Government affairs, Submission and registration, Features, Africa Tags: South Africa, Medicines Control Council, responsible pharmacist, harmonization initiative, CTD, dossier
Writing Skills for the Regulatory Professional

Later this year, RAPS will publish a new book, Regulatory Writing, co-authored and edited by Mukesh Kumar, PhD. This article is an introductory overview of his upcoming book and demonstrates that strong writing skills are a core competency of regulatory professionals.

Categories: Medical writing, Project management, Features, Communication Tags: writing skills, technical writing, writing training
'Cafeteria-Style' Approach to Training for the Regulatory Technical Writer

A flexible training methodology, referred to as the "cafeteria-style" approach, provides effective, efficient instruction for onboarding regulatory technical writers. This style of training is also useful in providing ongoing professional development for current staff.

Categories: Medical writing, Project management, Features, Communication Tags: regulatory writing, training, regulatory technical writers, training buckets
Writing Regulatory Documents with E-Submissions in Mind

Preparing regulatory documents for electronic submission (known as publishing) can be time consuming and complicated. This article offers some practical tips to help authors prepare regulatory documents in a more efficient manner, which can shorten submission timelines and save resources.

Categories: Medical writing, Project management, Submission and registration, Features Tags: electronic submissions, cross-referencing, hyperlinks, eCTD, templates, style guides, leaf titles
Types of In Vitro Diagnostics: Clearing Up the Confusion

In vitro diagnostics: It is easy to get lost in a seemingly foreign language of acronyms for IVDs—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? An overview of the various types of IVDs.

Categories: In vitro diagnostics, Features, US, FDA Tags: FDA, in vitro medical devices, IVDs, FDA guidance, GPRs, CLIA
Integrated Summaries of Effectiveness and Safety: Writing in the Context of the CTD

Two common approaches to writing Integrated Summaries of Effectiveness and Safety (ISE and ISS, respectively) and the Summaries of Clinical Efficacy and Safety are discussed, with the focus based on medical writers’ experience with document preparation for a US NDA or BLA. However, given that the Common Technical Document (CTD) format is accepted in the US, the EU and Japan, the same strategies also can be applied to those regions.

Categories: Biologics and biotechnology, Drugs, Medical writing, Submission and registration, Features, US, FDA Tags:
China FDA 'Flying Inspections' for Drugs: How They Work

The China Food and Drug Administration conducts special drug manufacturing inspections without advanced notice. These so-called “flying inspections” are in addition to regular GMP inspections. The article provides a summation of the key elements of CFDA’s proposed flying drug regulation, including its objective, scope, inspectors’ responsibilities and process.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Manufacturing, Features, China, CFDA, APIs Tags:
Fruit Flies––Powerful Foot Soldiers in Genetic Research

Fruit flies have revolutionized biological science since their research use began in earnest in the early 20th century. Some recent studies using fruit flies may have an impact on treatments for alcoholism, drug abuse, neurological and behavioral diseases, sleep, tumors and diabetes.

Categories: Drugs, Preclinical, Research and development, Features Tags: Fruit flies, Drosophila, research, genetics, history
Northern Africa: Regulatory Submission Considerations for the Region

Northern Africa is an emerging region presenting unique regulatory submission considerations.  Although sponsors usually seek to re-use key portions of a submission dossier to apply for approval in multiple Northern African countries, each national regulatory authority maintains specific regulations and procedures.

Categories: Drugs, Distribution, Regulatory strategy, Submission and registration, Features, Africa, FDA, EMA, WHO Tags: Africa, Northern Africa, regulatory submissions, Western Sahara, Mauritania, Morocco, Algeria, Tunisia, Libya, Egypt, Sudan
Canada and the Orphan Drug Framework--Where Are We Now?

Canada is in the final stages of developing an orphan drug policy for drugs affecting populations of 5 in 10,000 people. Bill C-17 has passed the legislature and is awaiting final approval. The new policy will then be open for comment. Fee mitigation, accelerated review and HTA collaboration are incentives but marketing exclusivity is not, although discussions on that topic are taking place. The final hurdle is provincial and private payment plans.

Categories: Prescription drugs, Orphan products, Government affairs, Reimbursement, Features, Canada, FDA, EMA, Health Canada Tags: orphan drugs, Bill C-17, Vanessa's law, payment plans
Applying Ethics to Conflicting Healthcare Philosophies: The Ebola Example and the RAPS Ethics Code

How regulatory professionals can apply the RAPS Code of Ethics to current and future endemic disease outbreaks characterized by a rapidly developing healthcare situation and quickly evolving knowledge base regarding prevention, treatment and potential cures.

Categories: Drugs, Ethics, Features, Africa Tags: Ebola, emerging diseases, treatments, prevention, potential cures
US Orphan Drug Exclusivity Criteria Clarified in Depomed Court Decision

Key points and observations about a recent federal court decision on orphan drug exclusivity as outlined in the case of Depomed v. US. The central issue concerned what conditions a drug must satisfy to qualify for marketing exclusivity.

Categories: Generic drugs, Orphan products, Features, US Tags: Depomed v US, orphan drugs, Neurontin, Gralise, post-herpetic neuralgia, exclusivity, clinical superiority
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