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Tag Archives: biologics
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
FDA Forms Biosimilar Work Group
In the end we are all separate: our stories, no matter how similar, come to a fork and diverge. We are drawn to each other because of our similarities, but it is our differences we must learn to respect. – … Continue reading
Posted in FDA, Industry News
Tagged biologics, biosimilar, CBER, CDER, FDA, Janet Woodcock
1 Comment
Drug/Biologic/Device Highlights from the Health Care Reform Bill
Cautious, careful people, always casting about to preserve their reputations… can never effect a reform. – Susan B. Anthony Last month, the company behind the FDA Law Blog, Hyman, Phelps & McNamara, P.C., prepared a memo that outlines the provisions … Continue reading
Biotech Wins Protection From Biosimilars
Love is the power to see similarity in the dissimilar. – Theodor Adorno When President Obama signed the healthcare reform legislation into law, he also handed a major victory to biotech companies. Unless you’ve been stranded on a deserted island … Continue reading
Posted in Industry News
Tagged biologics, biosimilar, follow-on biologics, healthcare reform, legislation, medical devices, obama, taxes
1 Comment
