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Tag Archives: biologics
New Informed Consent Requirements Improve Transparency in Clinical Trials
Trust, honesty, humility, transparency and accountability are the building blocks of a positive reputation. Trust is the foundation of any relationship. – Mike Paul Transparency of clinical research to participants and patients is what the FDA is going for with … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged biologics, clinical trials, drug product, FDA, FDAAA 2007, IND, regulations, regulatory affairs, safety, transparency
1 Comment
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
1 Comment
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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Use A Detailed Development Plan to Secure Venture Capital
It’s a tough time to be asking for money. Whether you’re a high schooler who needs cash to gas up the ride or a fledgling biotechnology company with a hot technology, there’s not much extra to go around. In today’s … Continue reading
Posted in Venture Capital
Tagged biologics, business plan, Cato BioVentures, CDRH, development plan, drug development, FDA, venture capital
1 Comment
FDA Ups the Ante on Transparency
Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one. – Helmut Jahn I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s … Continue reading
Posted in FDA, Industry News
Tagged 510(k), ANADA, ANDA, biologics, BLA, drugs, exclusivity, FDA, medical devices, NADA, NDA, patent, PMA, transparency
2 Comments
