• Feature ArticlesFeature Articles

    21st Century Cures Act and Acceleration of Device Approval

    This article discusses two critical provisions of the law meant to accelerate FDA approval of medical devices. It explains the benefits of the provisions, which have been criticized by consumer advocates in the past. Introduction It has been almost two years since the 21st Century Cures Act was signed into law, promising to modernize and accelerate the approval process for medical devices and other medical products. The US Food and Drug Administration (FDA) has attrib...
  • Feature ArticlesFeature Articles

    Benefit-Risk Management, Global Advertising, Promotion and Labeling Regulations and Regulatory Intelligence

    Feature articles over the past weeks have focused on the ability to assess and manage the benefit-risk profile of drugs, rules for updating prescription drug labels, off-label communications efforts, FDA’s role in regulating the advertising and promotion of prescription drugs, biologics and medical devices, the challenges of regulating mobile applications versus computers systems and recommendations for measuring regulatory compliance of complementary medicines. Researchi...
  • Feature ArticlesFeature Articles

    Regulatory Considerations and Best Practices for Promoting an Accelerated Approval Product

    This article discusses processes for the successful promotion of an accelerated approval product under FDA’s 1992 Accelerated Approval Program for drugs under 21 CFR Part 314 Subpart H and for biologics under 21 CFR Part 601 Subpart E. The author offers advice for working with the company’s commercial team and FDA’s Office of Prescription Drug Promotion (OPDP) reviewers and covers considerations for label updates to a multi-indicated accelerated approval product and consi...
  • Feature ArticlesFeature Articles

    Optimize Labeling and Advertising Outcomes through Targeted Subject-Matter Expertise

    This article discusses the importance of pharmaceutical labeling in terms of the strategies employed by labeling and advertising and promotions professionals and the benefits of working collaboratively. The authors address the usefulness of having teams of individuals from various backgrounds employing a variety of skill sets, all in the interest of launching a successful product with the enclosed packaging comprised of accurate and consistent information expressed clearl...
  • Feature ArticlesFeature Articles

    The Changing Regulatory Landscape of Advertising and Promotion

    This article provides two hypothetical “case studies“ demonstrating the impact of two recent FDA guidances for promotional communications that have the potential to change the US landscape of pharmaceutical regulatory advertising and promotion. The authors conclude that if regulatory professionals do ‘the right things,’ higher standards set forth by FDA in the new guidances will elevate the quality of pharmaceutical promotional communications to a ‘truthful and non-mislea...
  • Feature ArticlesFeature Articles

    Medical Device Marketing Under Substantial Equivalence—FDA Clearance and USPTO Patent Considerations

    This article focuses on medical device regulation by the US Food and Drug Administration (FDA) and medical device patent protection by the US Patent and Trademark Office (USPTO). The authors state most companies operating within the medical device space do not provide for sufficient interaction between those responsible for FDA approval and those responsible for patent protection. Because a “leak” of information about an invention during the FDA approval process before a ...
  • Feature ArticlesFeature Articles

    The Regulatory Strategist Toolbox: Clinical Endpoint Analysis Tools

    One of the critical parts of assembling a product’s “Strategy Playbook” or “Clinical Development Plan” is the researching and planning of clinical endpoints. This article discusses how to research endpoints, including tools to research them, how to organize the information and how to present the intelligence back to the team. Endpoints are measures intended to reflect the effects (efficacy endpoints) or safety (safety endpoints) of a drug or device. They include assessme...
  • Feature ArticlesFeature Articles

    Australian Regulatory Framework of Over-the-Counter and Complementary Medicine

    This article discusses Australia’s regulatory framework for Over-the-Counter (OTC) and complementary medicines as defined by the Medicines and Medical Devices Regulation (MMDR) and provides medicine-related classifications, types of postapproval changes, labeling, stability and advertising requirements. The author recommends measures for reinforcing regulatory compliance of complementary medicines. Introduction OTC and Complementary Medicine Australia has been acknowle...
  • Feature ArticlesFeature Articles

    Regulatory Challenges in Mobile Medical Applications

    This article presents the challenges associated with the regulation of mobile medical applications compared to computer software. The authors identify the differences between mobile applications and computer systems to determine the practical challenges of regulating these mobile applications as Software as a Medical Device (SaMD). This article also highlights various principles that can be followed to ensure patient safety and wellness by mobile application manufacturers...
  • Feature ArticlesFeature Articles

    Clarifying FDA’s Off-Label Promotion Efforts

    This article discusses off-label promotions and subsequent changes in related FDA guidances derived from the agency’s approaches to two First Amendment cases and recently enacted state laws regarding off-label communication. The authors suggest that Federal court challenges, newly enacted laws and the value of off-label information from a clinical practice and health economic perspective have pressured FDA to “fine-tune” interpretation of its regulations to make them more...
  • Feature ArticlesFeature Articles

    Canadian Drug Advertising Regulations

    This article discusses Canadian drug advertising regulations and focuses on applicable laws from Health Canada and various other Canadian regulatory bodies. The author stresses the importance of understanding what Canada considers advertising, the limitations on marketing efforts and whether healthcare product advertising is aimed at healthcare providers, patients or general consumers for companies outside of Canada who want to enter the Canadian market and advertise thei...
  • Feature ArticlesFeature Articles

    Pregnancy and Lactation Labeling Rule: Strategies for Updating Prescription Drug Labels for Compliance

    This article outlines the process by which a sponsor can update a previously approved United States Prescribing Information (USPI) to be compliant with FDA’s Final Rule Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (79 FR 72063) published in 2014. The Final Rule introduced significant changes to the format of the USPI for prescription drug and biological products. Commonly referred ...