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The latest from the Agency that you need to know.
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The latest from the EU.
The recent federal trial court decision in <i>Dusek v. Pfizer Inc.</i>, Civil Action No. H-02-3559 (S.D. Tex. 2/20/04) dismissing plaintiffs' products liability claims against Pfizer in connection with the prescription drug Zoloft' on the ground of conflict preemption has given the pharmaceutical industry some hope that compliance with Food and Drug Administration (FDA) regulations will afford protection from common law failure-to-warn claims. The court granted summary judgment on the ground that a cause of action based on the plaintiff's proposed additional warning to the product label that Zoloft can cause suicidal ideation would conflict with the FDA's decision not to add such a warning because no causal link had in fact been established and it would in effect be false and misleading in violation of federal law. This should not deter continued efforts to obtain tort reform at the state level, however, where the continued influx of pharmaceutical product liability claims continues to burden courts and the pharmaceutical industry.
The latest news of interest to you and your practice.
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Restriction practice (ie, the restriction of a patent application to prosecution of a single claimed invention per filing fee) has been around since the mid-1800s. In recent years, hyperproliferation of restriction requirements, especially in the biotechnology, chemical and software arts, has occurred. It has not been uncommon for the U.S. Patent and Trademark Office (PTO) to assert that a patent application contains 10, 20, even 100 distinct inventions.
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In last month's newsletter, we looked at some helpful Web sites for those who need to track the efficacy and safety of medical devices. Following are more useful Web sites for these purposes.
Recent rulings of importance to you and your practice.
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As of Jan. 7, 2004, pursuant to Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, agreements between brand-name and generic pharmaceutical companies regarding the manufacture, marketing, and sale of generic versions of brand-name drug products are required to be filed with the Federal Trade Commission and the U.S. Department of Justice.
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Recent rulings of importance to your practice.
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How do the medical device industry and the FDA prevent risks to the end user once the product is marketed? There is no simple answer to this question. Post-market vigilance in terms of risk assessment involves complex issues. These issues involve a cost/benefit analysis in terms of a "best approach" to post-market co-vigilence.