Regulatory
Supporting Innovation Through FDA’s Breakthrough Device Program
Similar to the drug industry’s paradigm for Breakthrough Therapy Designation, the device industry’s opportunity ...
How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels
When developing content for new drug labels, life sciences companies’ regulatory teams face challenges ...
Rob Califf and the Future of Accelerated Approval
If the regulatory, policy, and political temper tantrums over the FDA’s approval of Exondys ...
Digital Therapeutics Companies Lean into Decentralized Clinical Trials
While digital therapeutics (DTx) companies are extremely optimistic about the promise of software-based interventions ...
Bringing Clarity to Cannabis-Based Product Conundrums
The 2018 Farm Bill redefined the meaning of hemp, opening the door to small ...
3 Key Considerations for Promoting Transparency for AI/ML-Enabled Medical Devices
Today, developers of innovative medical devices are increasingly utilizing artificial intelligence (AI) and machine ...
The Steps to Take for a Rx-to-OTC Switch in the United States
Nearly 40% of all the over-the-counter medications in the U.S. were initially marketed as ...
How to Accelerate the Approval Process for Marketing Materials Within the Life Sciences
Thanks to the exponential growth of the internet and the rapid take-up of technological ...
Common Pitfalls That Can Be Avoided During Clinical Development
During the clinical development of pharmaceuticals, it is not uncommon for a program to ...
Expedite the MLR Review Process—Engage Audiences with Your Content Faster
How are you approaching audience engagement at your organization? Perhaps you’re putting an emphasis ...
How COVID Has Reshaped the Clinical Trial Regulatory Landscape
The concept of patient centricity is hardly new, but in recent months it has ...
Promotion of Devices Subject to the FDA’s COVID-19 Enforcement Policies
On April 16, 2021, the FDA announced the withdrawal of their January 15, 2021 ...
Every Pharma Marketer Should Apply These Regulatory Safeguards
In March, I had the opportunity to participate in a panel at DIA. The ...
