Regulatory Sciences
Navigating a Shifting Regulatory Landscape: The Impact of FDA Layoffs on Medical Device Developers
On Thursday, March 27, 2025, HHS announced that they would be conducting a reduction in force impacting nearly 3,500 full time FDA employees – nearly 20% of the Agency’s entire workforce. This comes...
Regulatory Sciences
FAQs: Model Informed Drug Development (MIDD) & Modeling and Simulation (M&S)
Question & Answer with Sander Vinks, PhD, PharmD, FCP, Regarding MIDD and M&S In the ever-evolving landscape of drug development, efficiency, precision, and regulatory success are paramount....
Regulatory Sciences
The End of the FDA’s Rare Pediatric Disease Priority Review Voucher Program
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
Regulatory Sciences
Challenges in Clinical Development of Products for Rare Disease
Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States. There are over 7,000 rare diseases affecting more than 30 million...
Regulatory Sciences
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...
Regulatory Sciences
FDA Releases Final ICH M13A Guidance Document
On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...
Quality & Compliance
The Evolving Landscape of Quality Management Systems in the Life Sciences Industry
In the decades since the FDA first introduced Good Manufacturing Practice (GMP) regulations, the drug and device industry has undergone significant transformation. While the core principles of...
Medical Information
Enhancing Animal Health Compliance with Comprehensive Medical Information (MI) and Pharmacovigilance (PV) Services
Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and...
Quality & Compliance
Diary of Compliance: A Year in the Life of Ensuring FDA CAPA Standards
Welcome to the Diary of Compliance, where we follow the journey of Allison Audit, the dedicated and detail-oriented Quality Assurance Manager at Acme Pharma. Over the course of a year, Allison takes...
Clinical Research Solutions
The Care and Feeding of FDA PMAs: Mastering Premarket Approval
Congratulations, FDA has approved your PMA! Now what? Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's...