iwewlkws 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 However, the AA is a conditional approval that can be withdrawn if the conditions are not met.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
The FDA’s audits or inspections of manufacturing facilities are critical to ensuring the availability of high-quality regulated products to US consumers. The Government Accountability Office (GAO) has raised issues with FDA auditing practices over the years. GAO’s latest report highlights a practical reason that may be affecting FDA audits: the cadre of its inspectors. FDA … Read more
Designing non-clinical toxicity studies is challenging for any new product due to several guidance documents providing seemingly similar but different perspectives on regulatory requirements. This week the FDA released a guidance document describing strategies for non-clinical study plans for oligonucleotide products. More than 20 guidance documents describe the non-clinical study requirements for all drugs and … Read more
Patients trust their doctors for medical information. Previously it has been argued that the rampant misinformation on the internet about medical topics can be countered by patients conferring with their doctors. But what happens when that very source, the doctor, spreads misinformation? Do the medical boards, whose job is to regulate the medical profession, penalize … Read more
