Regulatory Sciences
FDA Adds Bemotrizinol to OTC Sunscreen Monograph: What the New GRASE Determination Means for Manufacturers
On June 10, 2026, FDA issued a final administrative order (OTC000039) amending the OTC monograph for sunscreen drug products to include bemotrizinol as a generally recognized as safe and effective...
Regulatory Sciences
Accelerating European Market Entry: The Strategic Advantage of Using FDA Approval in the UK’s IRP
The UK’s Evolving Role in Global Regulatory Strategy Since Brexit, the United Kingdom has continued to reshape its regulatory framework with a strong emphasis on innovation, agility, and accelerated...
Regulatory Sciences
IND Readiness Isn't a Checkbox Exercise, It's a Regulatory Risk Management Strategy
Why Sponsors Should Pressure-Test Their IND Before Submission For many sponsors, the Investigational New Drug (IND) application is viewed as a procedural milestone, the point at which a development...
Regulatory Sciences
Cyberattacks in MedTech: Lessons from Stryker, Intuitive, & FDA's Cybersecurity Expectations
Cybersecurity threats are no longer theoretical risks for medical device manufacturers. They are operational, regulatory, and patient safety events unfolding in real time. Recent cybersecurity...
Regulatory Sciences
The IND is More Just an FDA Submission: It’s a Regulatory Positioning Strategy
For decades, FDA's Investigational New Drug (IND) application has been viewed primarily as a regulatory gateway. Submit the application, obtain FDA's approval to proceed, and begin clinical trials....
Regulatory Sciences
Skinny Labels Under the Microscope: What Hikma v. Amarin Means for Drug Developers
In today's evolving regulatory and legal landscape, few issues are as consequential for generic drug development as the use of so-called "skinny labels." The recent decision by the U.S. Supreme Court...
Regulatory Sciences
ANDA Development Made Clear: Expert Advice on Submission Strategy, Labeling, and Patent Considerations
Inside our Q&A session with former FDA labeling reviewer, Marshall Florence, PharmD., regarding ANDA submission strategy, labeling, and how to effectively use the OrangeBook as a strategic resource....
Regulatory Sciences
Marketing Authorization and Market Access: Navigating Pricing & Reimbursement Before and After Approval in Europe
For decades, pricing and reimbursement activities have been handled separately from the regulatory process and typically only began once regulatory approval was secured. This separation has largely...
Regulatory Sciences
FDA's Shift to One Pivotal Trial for Drug Approval: Regulatory Strategy Implications for Sponsors
In a move that could reshape modern drug development, on February 19, 2026, FDA formally confirmed that one adequate and well-controlled pivotal trial may now serve as the default basis for drug...
Regulatory Sciences
Preparing for eCTD 4.0: What FDA Submitters Need to Know
Why Early Planning Matters for Regulatory Operations While it's only been a handful of years since eCTD Version 3.2.2 became the standard submission format for all major components of US regulatory...
Regulatory Sciences
2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026
2025 was a year of significant regulatory disruption. One that will have lasting implications for how pharmaceutical companies approach advertising and promotion in 2026. From an unprecedented surge...
Regulatory Sciences
Influencers in Pharma: A Growing Compliance Frontier
As digital marketing evolves, prescription drug promotion is expanding into spaces traditionally dominated by consumer brands. Pharmaceutical companies are increasingly collaborating with...
Regulatory Sciences
Reclaiming the European Market: How to Secure EU/UK MAH Status Without the Local Infrastructure
For many US and APAC pharmaceutical companies, reacquiring the European rights to a successful, out-licensed product is a smart strategic move — an opportunity to capture greater margins, regain...
Regulatory Sciences
FDA Tightens the Reins on DTC Drug Ads: Big Picture Insights and Industry Implications
On Tuesday, September 9, 2025, the Department of Health and Human Services (HHS) and FDA both issued press releases and a fact sheet launching a crackdown on deceptive drug advertising. In the FDA's...
Regulatory Sciences
Tips for Preparing Successful FDA 510(k) Submissions
Securing FDA clearance through the 510(k) process is a critical milestone for many medical device manufacturers seeking market entry in the US. While the pathway is well-defined, many submissions...
Regulatory Sciences
FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2025
On September 25, 2025, FDA posted an additional 11 Untitled Letters from the cohort of letters issued on September 9, 2025, bringing the total number of compliance letters directed toward...