This guideline lays down the non-clinical and clinical requirements for interferon beta (IFN-β)
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What’s New
- 2011.12.22
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[Guidance for Industry] FDA announced a guidance ｆor industry regarding ‘Regulatory Classification of Pharmaceutical Co-Crystals (DRAFT GUIDANCE)’ (Published 12/1/2011 )
In response to the need for regulatory guidance, this draft guidance provides our current thinking o…more
- 2011.10.12
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“[Guidance for Industry] FDA announced a guidance dor industry regarding ‘Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting’. (Published 10/11/2011 )”
Pharmaceutical manufacturers aiming to thwart drug product counterfeiting have been investigating re…more
- 2011.10.08
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European Medicines Agency invites feedback on plans to revise existing guidelines on biosimilar medicines and influenza vaccines (Published 2011/10/3)
The European Medicines Agency (EMA) published a concept paper on its proposed revisions to the agenc…more
