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Tag Archives: generic drugs
Recap of the DIA Annual Meeting 2011
The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, … Continue reading
Posted in Uncategorized
Tagged AIDS, biologics, biosimilar, Cato Research, CBER, CDER, clinical trials, DIA, EMA, EU, FDA, follow-on biologics, generic drugs, geriatric, GMP, guidance, HIV, marketing application, oncology, Orphan Drug Designations, pediatric, pharmacovigilance, pre-IND
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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
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
