Many clinical trials involve collecting tissues from trial participants as a part of the clinical protocol which inherently adds varying degrees of risk to the participants. The FDA has specified conditions under which biopsies could be collected and the processes involved to adequately control the amount, type, and quality of the tissue sample collected in … Read more
Investigating and addressing deviations in the manufacturing process is a critical requirement for compliance with Good Manufacturing Practices (GMP). A Warning Letter (WL) issued to Sanofi’s drug manufacturing facility in Paris highlights the procedural deficiencies that all manufacturing facilities should address to stay GMP compliant. Deviations from the process could happen for various reasons. … Read more
A few controversial approvals in the last decade have clouded the public perception of the Accelerated Approval (AA) pathway. The Congress last year gave the FDA an additional mandate to enforce timely completion of the post-market clinical trial commitments thereby increasing the burden of maintaining the approval on the sponsors. The AA pathway’s credibility relies … Read more
The U.S. Food and Drug Administration (FDA) approved 50 new drugs last year, which is at par with the average of about 50 new drug approvals each year that the FDA has maintained over the last decade. There are some trends that have continued this year and could help developers strategize for the years to … Read more
The FDA’s new year gift to the industry is a record-breaking reading assignment; it released 31 Guidance documents on the first Monday and Tuesday of the year. In an unprecedented data dump of sorts, the guidance documents span all centers at the Agency. This is not normal by any standards but how does it impact … Read more
The U.S. Food and Drug Administration (FDA) recently updated its guidance titled “Registration and Listing of Cosmetic Product Facilities and Products.” This document aims to help cosmetic businesses understand the requirements for registering their facilities and listing their products with the FDA. The updated guidance includes finalized frequently asked questions (FAQ) in Appendix B, specifically … Read more
FDA’s Accelerated Approval (AA) pathway has often been a subject of public criticism due to the apparent approval of inefficient drugs based on preliminary and/or partial efficacy data. However, the AA is a conditional approval that can be withdrawn if the conditions are not met. This week, the FDA released a new guidance document whose … Read more
Medical devices containing Artificial intelligence (AI) and Machine Learning (ML) technologies inherently require updates as the software self-trains on the data generated internally, improving their performance over time which, in turn, triggers the threshold of a new 510k or a PMA amendment creating regulatory burden for the manufacturer. A new FDA guidance document provides a … Read more
The U.S. Food and Drug Administration (FDA) recently released two reports outlining its strategies for improving communication with stakeholders and developing guidance documents. The report on communications lists seven ways the FDA communicates with stakeholders, while the report on guidance documents describes the process to create new or update guidance documents, standardized format, and review … Read more
The number of cell and gene therapy (CGT) products has increased steadily over the last decade using traditional product development guidance documents. Although the FDA has released about 37 guidance documents governing the requirements for these products, developers frequently need additional help to define the specific non-clinical, clinical, and manufacturing requirements. A new FDA Guidance … Read more
