FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|September 2, 2003
- Pharmaceutical Technology-09-02-2003
- Volume 27
- Issue 9
Counterfeiting, Compliance, and Controls
Author(s)Jill Wechsler
FDA and manufacturers seek to curb drug counterfeiting while legislators consider liberalizing drug importing policies to cut pharmaceutical costs.
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The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.
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Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
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