How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation
Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. (Downloadable storyboard template included.)
Janssen v. Celltrion Federal Circuit Judgment: What Biosimilar Makers Need To Know
The Federal Circuit recently issued Rule 36 judgments in two separate BPCIA cases: Genentech v. Amgen and Janssen v. Celltrion. This two-part article series explores some of the unanswered questions raised in these two cases. In Part 1, Genentech v. Amgen was discussed. Here, Part 2 delves into the remaining questions following Janssen v. Celltrion.
Genentech v. Amgen Federal Circuit Judgment: What Did We Learn?
The Federal Circuit recently issued Rule 36 judgments in two separate BPCIA cases: Genentech v. Amgen and Janssen v. Celltrion. Because the Federal Circuit decided both appeals without opinion, several open questions remain unresolved regarding BPCIA litigation. This two-part article explores those questions, starting with Genentech v. Amgen.
The Global Regulatory And Quality Environment For Biopharma Outsourcing
It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.
Regulatory Implications Of The CARES Act On Over The Counter Drugs
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, passed in response to the COVID-19 pandemic, reforms how OTC drugs are regulated in the U.S. In announcing the legislation, the FDA called the changes a “landmark step that will have an impact lasting long after the current public health emergency.”
Canaries In A Coal Mine: Can Data Integrity Thwart A Deepfake Threat?
If you think deepfake security risks are purely science fiction, think again. Not only does the technology exist and the content is readily available to facilitate such activities, but incentives to carry them out are multiplied in the current economic, social, and political environment.
Merck, Walmart, IBM, & KPMG’s FDA Blockchain Pilot: What We Learned
IBM, KPMG, Merck & Co., and Walmart successfully completed an FDA pilot program that demonstrated how blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to verify, track, and trace prescription medicines and vaccines distributed within the U.S.
A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided
Some leaders in the pharma, biopharma, and med device industries believe hiring consultants is quicker and more efficient than hiring a full-time employee. Does this thinking fail to factor in the investment required for thorough recruiting and training to ensure a successful engagement?
Are You Ready? FDA’s Transition From Computer System Validation To Computer Software Assurance
The FDA is preparing to release new guidance, "Computer Software Assurance for Manufacturing, Operations and Quality Systems Software," in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.
An Update On Regulatory Guidance For U.S. Clinical Trials During COVID-19
To preserve integrity in clinical trials and mitigate the need to place clinical trials on hold indefinitely, the FDA has issued updated guidance to support important research and exploration of new treatments. Additionally, the U.S. Department of Health and Human Services’ Office of Human Research Protection issued guidance to assist researchers in applying human subject protection regulations.