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Searching Content indexed under Food and Drugs Law by Philip Katz ordered by Published Date Descending.
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FDA Guidance May Ease Path To Biosimilar Interchangeability
On Friday, FDA published the final guidance, "Considerations in Demonstrating Interchangeability With a Reference Product," which is intended to assist sponsors ...
United States
5 Jun 2019
2
FDA Publishes Final Guidance On ANDA/505(B)(2) NDA Pathways
On Thursday, FDA published the final guidance document, "Determining Whether to Submit an ANDA or a 505(b)(2) Application" that contains minor revisions ...
Belgium
28 May 2019
3
China Adds 30 Drugs To Its "Urgently Needed" List
On 28 March China's National Medical Products Administration (NMPA) published a list of an additional 30 drugs that are "urgently needed" in China ...
United States
15 Apr 2019
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