fda

FDA oversight is fundamental to ensuring that healthcare products in the U.S. meet strict safety and effectiveness standards. Staying current on FDA regulations and expectations is essential for successful product approval. Explore the blog posts on this page for insights into FDA processes and updates.

Regulatory Sciences

Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development

Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track The FDA has recently undergone a wave of layoffs that are beginning to...

Regulatory Sciences

Navigating FDA Layoffs: OPDP Cuts and the Rising Stakes of Ad Compliance

The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food...

Business Professionals Having Stressful Meeting

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....

child-receiving-medical-care-rare-disease

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....

Doctor holding a patient's hand over a desk

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...

FDA Recommendations for Confirming an Ames Positive Finding

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On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...

final fda guidance ich m13A requirements

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...

Health care professional meeting virtually with another healthcare professional

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...

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