Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA.
Are you among the many who will be impacted when the comments period is over, and the final Guidance is issued?
Our current Contract Pharma article, “Get Ready for a New Approach to cGMP Inspections,” pulls back the proverbial curtain to reveal key areas of the proposed FDA Guidance, including Remote Regulatory Assessment (RRA), Remote Interaction Evaluation (RIE), and highlights the use of “Inspections Conducted by Foreign Regulatory Partners.”
This timely, and highly informative article by Bob Kelly, Principal Consultant, Lachman Consultant Services, Inc. is a comprehensive outline of this most recent FDA draft Guidance for ANDAs, Biosimilars, BLA, FDA, Generics, NDA Regulatory Affairs. It also highlights the FDA’s intent to use remote subject matter experts (SMEs) to facilitate timely decisions on applications as well as required response times for observations issued and corrective actions identified.
Read the Contract Pharma article here.