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...
Regulatory Sciences
Decoding FDA’s Recent Advertising Enforcement Actions
The Agency’s Advertising Enforcement Letters Reveal Shifting Regulatory Priorities On Tuesday, September 16, 2025, FDA posted 40 Untitled Letters and 8 Warning Letters directed at prescription drug...
Regulatory Sciences
FDA Launches Crackdown on Deceptive Drug Advertising
On September 9, 2025, the US Department of Health and Human Services (HHS) and FDA unveiled a sweeping effort to clamp down on misleading direct-to-consumer (DTC) pharmaceutical advertising. The...
Regulatory Sciences
FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?
On September 4, 2025, FDA announced a sweeping policy change: the real-time release of Complete Response Letters (CRLs); a continuation of FDA's July 10, 2025 publication of previously undisclosed...
Regulatory Sciences
Transparency Requirements and the Requirement for Document Redaction
In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the...
Regulatory Sciences
MAH Expertise Across Eastern Europe — and Beyond
Navigating pharmaceutical regulations across multiple countries isn't just about knowing the rules — it's about understanding the rhythm of each market, responding quickly to change, and having the...
Regulatory Sciences
MLR Submission Checklist: Preparing for Speed and Compliance
Pharmaceutical, biotech, and MedTech companies invest significant time and resources into developing promotional materials, only to face avoidable delays during the Medical, Legal, and Regulatory...