Advertising, Promotion and Labeling, Accelerated Approval and Regulatory Science

Feature ArticlesFeature Articles | 02 November 2018 | Citation

October feature articles covered the following topics:

  • the changing advertising and promotion landscape
  • labeling
  • accelerated approval regulations for drugs and devices
  • comparability bridging studies for combination products
  • FDA resources
  • regulatory science

In January 2017, the release of two guidance documents shook the pharmaceutical advertising and promotional landscape and, consequently, affected the “risk tolerance” level of regulatory professionals. In “The Changing Regulatory Landscape of Advertising and Promotion,” Georgina Lee and Richard Lem evaluate the potential impact of these guidances, which may change the US pharmaceutical regulatory advertising and promotion landscape. If regulatory professionals do ‘the right things,’ FDA’s higher standards in these new guidances will elevate the quality of pharmaceutical promotional communications to a ‘truthful and nonmisleading’ level, ultimately benefiting patients.

Leading regulatory experts Julie Batal and Kristen Heinlein address the importance of pharmaceutical labeling and focus on strategies and the benefits of working collaboratively. Their article, “Optimize Labeling and Advertising Outcomes through Targeted Subject-Matter Expertise,” stresses the value of multi-disciplinary teams working together to launch a successful product, complete with accurate and consistent information—expressed clearly and concisely for both physicians and patients—enclosed in the packaging.

Regulatory Considerations and Best Practices for Promoting an Accelerated Approval Product” 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. Senior regulatory affairs associate Cara Diehl offers advice for commercial teams working with FDA’s Office of Prescription Drug Promotion (OPDP) and covers considerations for label updates to a multi-indicated accelerated approval product and for consumer directed promotional materials.

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. Medical device solutions expert, Alex Butler, describes two critical provisions of the law meant to accelerate FDA approval of medical devices in “ 21st Century Cures Act and Acceleration of Device Approval” and explains the benefits of the provisions.

John Towns and a number of regulatory experts, discuss comparability, bridging, combination products and human factors. “RAPS Workshop Proceedings: Comparability Bridging Studies for Combination Products” highlights presentations given during a RAPS combination products workshop and documents an FDA panel discussion, group exercises, case studies and considerations regarding bridging studies that have already been implemented into the study plans of sponsors in attendance with the potential of being incorporated into future regulatory guidance. The authors include FDA and industry opinions along with the suggestions made by participants.

FDA’s Small Business and Industry Assistance (SBIA) Program helps both large and small pharmaceutical companies navigate drug development regulations facilitate products into the marketplace. In FDA’s Small Business and Industry Assistance Program: A Helping Hand to Small Pharma, SBIA advocate Renu Lal discusses various FDA resources available, including services, programs, conferences, Webinars, tutorials, other online information and various communications services.

Regulatory science is the discipline of overseeing, creating and implementing innovation for global health needs. In “ Theoretical Perspectives of Technology for Regulatory Science: Part 1,” regulatory scientist Jan Fourman provides a foundational regulatory philosophy of technology and illustrates the purpose of regulatory science and tools practitioners can use to challenge current constructs on medical availability and drug/device development approval processes. She’ll continue this dialog in a follow-up article.

What’s coming in November?

Feature articles will cover a variety of topics, including an update on biosimilars and global IVDs, regulatory information management, GMP auditing and consumer advertising regulations. Part 2 of Theoretical Perspectives of Technology for Regulatory Science will also be available in November.

More From Regulatory Focus

And don’t forget to look for the upcoming Regulatory Focus Article Series on advertising, promotion and labeling regulations. Scheduled release date is 12 November.


Send comments and recommend topics for a feature article or series to I welcome your feedback.


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