Consultation Process Initiated by the Natural Health Products Directorate ("NHPD")
NHPD has initiated a consultation process to seek feedback on changes proposed to the current NHP site licensing model and the Good Manufacturing Practices ("GMP") standard for NHPs as well as to the information required at the time a product licence application is submitted. Proposed changes have been outlined in the document entitled "A New Risk-Based Approach to Site Licensing for Natural Health Products" available on the website of Health Canada. The consultation is opened until October 28, 2011.
U.S. Food and Drug Administration ("FDA") Issues Draft Guidance on Trial for Class III Devices
The FDA has issued a draft guidance which outlines the agency's expectations around clinical trial design issues for pivotal clinical studies performed to support pre-market approval (PMA) applications for Class III medical devices, the highest risk category of medical devices.
New Rules Relating to Financial Conflicts of Interest in Biomedical Research
Last August, the U.S. government released new final rules that will tighten up oversight of financial conflicts of interest in biomedical research. The rules are similar to draft regulations released in May of last year, but the requirement aimed at informing the public about conflicts has been watered down. Also, the previous researcher's income threshold of $10,000 per year has been lowered to $5000 and broadened to include any participation in a non-publicly traded company.
Lack of "Good Faith" Not a Ground for Patent Invalidity in Canada
In July, the Federal Court of Appeal ruled out that a patent cannot be later invalidated on the grounds that an Applicant did not act in "good faith" during prosecution of the application.
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