Search Results for Sharry Arora

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FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities By Sharry Arora - Published 14 July 2017

The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).

Categories: Features, US, FDA, Compliance, Drugs, Manufacturing

Tags: Oral Solid Dosage, OSD, Inspections

Conditional Approvals for Early Access to New Medications By Sharry Arora - Published 31 May 2017

This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US.

Categories: Features, Japan, Europe, US, EMA, FDA, ICH, PMDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Conditional approval, Regenerative medicine