iwewlkws FDA’s enforcement policy for the distribution of off-label or unapproved information by manufacturers has come a long way in the last decade; from very conservative to reasonably flexible where companies can share off-label information freely provided they follow some basic rules prohibiting overt promotion using such information. This week’s new FDA guidance adds to the … Read more
Last week, the FDA directed a South Korean drug manufacturer to hire a consultant to help with numerous non-compliance observations during an audit of their manufacturing facilities in South Korea. Such “suggestions” to audited parties to hire external experts are occasionally made in Warning Letters. But are the manufacturers obliged to follow through? FDA audits … Read more
Earlier this month, the FDA issued a Warning Letter to an online pharmacy selling a generic version of GLP-1 analog, semaglutide, and in the process highlighted the limitations of such FDA actions for online pharmacies selling illegal products. So long as the consumers are willing to risk buying products online from dubious companies, the FDA … Read more
Earlier this year, Pfizer suddenly dropped 3500 patients participating in a clinical trial to evaluate its vaccine for Lyme disease citing violation of Good Clinical Practices (GCP) at its CRO vendor. This week, the CRO announced that it was audited by FDA inspectors who found no violations. So, did Pfizer make the wrong decision to … Read more
Animal studies are critical for demonstrating the safety of a product prior to the initiation of human clinical trials. Clinical trials will not be allowed to proceed by the FDA if any major product-related safety issues are observed in animal studies. But did Elon Musk’s company get a break from this policy or lie to … Read more
Starting October 1, 2023, FDA no longer accepts paper 510k submissions. As announced before, 510k applications must be created using the eSTAR template and submitted electronically to the FDA for review. This week FDA released the final guidance for the electronic submission of 510k applications, confirming what it proposed about a year ago. Some important … Read more
For the last 15 years, the FDA’s attempts to regulate Lab Developed diagnostic Tests (LDTs) were rebuffed due to the lack of political will for such regulation or public support. FDA unsuccessfully tried to get Congress to pass new LDT laws, and its proposed guidance documents to regulate LDTs were derailed by strong opposition from … Read more
Cybersecurity requirements for FDA-regulated devices are evolving rapidly to stay in step with technological developments. This week the FDA released a detailed guidance document addressing several security issues around medical devices connected to the internet currently in development. The directions in this guidance document could append the ongoing development plans for internet-connected medical devices or … Read more
Meeting the FDA is unquestionably the most important resource available to sponsors/developers of new drugs and biologics. Over the last 30 years, these meetings have evolved into complex procedures. Their potential outcomes depend not on just what you ask but how you ask and when you ask the FDA about a particular issue related to … Read more
There have been numerous controversial decisions by the FDA in recent years where it approved new drugs despite its Advisory Committees (AdCom) recommending against it. But the FDA, being an equal opportunity disagreer, at times also rejects drugs that were recommended by its AdCom for approval as was shown this week when it rejected an … Read more
