Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty?
The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.
How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data
Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?
A Quality Agreement Primer: Managing Risk When Working With Contractors
This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.
Hazmat Regulations: What Life Sciences Companies Need To Know
It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.
FDA Releases Guidance On Normal GMP Operations During COVID-19
Most FDA guidance on COVID has been associated with tools to combat the pandemic. This new guidance should be read by all drug and biologic manufacturers, whether or not they produce COVID-related products.
Unpacking FDA’s New Guidance On Controlling Nitrosamine Impurities In Drugs
On Sept. 2, 2020, the Federal Register announced the availability of a final FDA guidance, "Control of Nitrosamine Impurities in Human Drugs." This guidance is immediately effective and was not subject to the usual comment period “…because of the importance of providing timely information to manufacturers regarding risk assessments, testing, and other appropriate actions they should take."
How FDA Is Helping Advance Clinical Trial Diversity
An update from the FDA Office of Minority Health and Health Equity on its efforts to address health disparities and health equity — and ultimately strengthen the agency’s ability to respond to minority health concerns.
An Update On 2020 U.S. Biosimilars Regulation & Litigation
The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.
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.