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Author Archives: Leo DiNapoli
Generic Lovenox – Moving One Step Closer to Biosimilars
We bleed from similar veins. – Tupac Shakur Lovenox is not, I repeat, not a biologic therapeutic. It is derived from a biological source (pig intestines, yum), but it is not protein-based. However, the FDA’s approval of a generic form … Continue reading
Posted in FDA, Industry News
Tagged biologics, biosimilar, drug development, FDA, generic drugs
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HHS Proposes Changes to HIPAA
Image via Wikipedia Privacy is not something that I’m merely entitled to; it’s an absolute prerequisite. – Marlon Brando On July 8th, the Department of Health and Human Services (HHS) announced that it was proposing changes to Health Insurance Portability … Continue reading
OIG Report Shows Increasing Use of Foreign Clinical Trials in Marketing Applications (and Challenges for the FDA)
There are no foreign lands. It is the traveler only who is foreign. – Robert Louis Stevenson Global. That’s one of the buzz words/ideas that has gripped modern drug development. In particular, there is a notion that foreign countries represent … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged biologics, BLA, clinical trials, drug development, FDA, GCP, IND, inspections, marketing application, NDA
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FDA Begins Releasing Safety Analyses of Recently Approved Products
The safety of the people shall be the highest law. – Marcus Tullius Cicero Evaluating drug safety is, as I’m sure you know, always an exercise in measuring risks and benefits. One question that can haunt the dreams of companies … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged clinical trials, FDA, FDAAA, postmarketing
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FDA & NIH Launch Electronic Safety Reporting Portal
Biology will relate every human gene to the genes of other animals and bacteria, to this great chain of being. – Walter Gilbert The FDA and the NIH have announced a joint venture called the Safety Reporting Portal (SRP). The … Continue reading
Posted in FDA, Industry News
Tagged adverse events, clinical trials, drugs, FDA, human gene transfer, IND, NIH, pharmacovigilance, safety
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