JD Supra

New Draft FDA Guidance for Dietary Supplement Master Files

FDA has developed a new set of requirements for documenting the safety of dietary supplement ingredients. Manufacturers are able to market products with new ingredients without preapproval as long as ...
JD Supra

Dietary Supplements: FDA Issues Draft Guidance on NDIN Master Files

On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...
RAPS

FDA Delays eCTD Requirements for Master Files

The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised ...
Threat Post

Petya Ransomware Encrypts Master File Table

The Petya ransomware encrypts a compromised computer’s master file table. First ransomware locked your desktop. Then it encrypted your files. Not long after, webservers, shared drives and backups were ...
RAPS

EMA Offers Draft Guideline on Trial Master Files

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial ...