Perspectives - Page 26

Demonstrating the Value of Drugs for Rare Diseases – 8 Common Challenges and How to Address Them Before They Arise

No matter how robust in design, clinical trials can never fully address the uncertainty surrounding the comparative effectiveness and safety of a novel product in the real world.

Whitepaper Jul 8, 2020

The Use of Genetic Testing in the Courtroom: Dr. David Schwartz will be Presenting at the IADC 2020 Virtual Annual Meeting

View Jul 2, 2020

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

View Jul 1, 2020

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

View Jun 25, 2020

NDA Versus OTC Monograph: Which Pathway is Right for You?

View Jun 22, 2020

Four Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that the FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market.

View Jun 19, 2020

Will the FDA Authorize Your Product Health Claims?

View Jun 15, 2020

OTC Monograph User Fees are Cancelled for FY2020

View Jun 11, 2020

Focusing on Professional Growth in 2020

View Jun 11, 2020

Differences between FDA COVID-19 Guidance for Alcohol-Based Hand Sanitizers and Monograph Hand Sanitizers Containing Alcohol

View Jun 8, 2020

FDA Requirements for Coronavirus Tests with At-home Specimen Collection

Although FDA continues to streamline its process to submit a package requesting an Emergency Use Authorization (EUA) letter for SARS-CoV-2 diagnostic tests, it can be challenging and the precise nature of the submission must be followed.

View Jun 4, 2020

Asset and Brand Planning – What Do We Do Differently When the Future Has Shifted?

Jun 2, 2020

FDA Announces New Changes to Permitted Marketing Status of OTC Monograph Drugs

View Jun 2, 2020

How to Apply for an FDA Coronavirus Emergency Use Authorization Letter

Whitepaper May 27, 2020

When the Wheels Fall Off the Brand Planning Cycle

May 26, 2020

Medical Affairs Unscripted | Stakeholder Engagement with Dan Hennessy

Peg Crowley PhD, MBA meets with Dan Hennessy PhD, MBA, Vice President of Strategic Excellence at EMD Serono to discuss a fresh look at the complexity of the matrix of stakeholders who play a critical role in the patient care cycle.

Podcast May 21, 2020