May 1, 2018 | Drug and Device Corner, Drugs, Medical Devices
Reminder! 5 May 2018 is the date for DMF (Drug Master File) and IND (Investigational New Drug) applications to comply with eCTD format submission. There has been a delay for Type III DMF files to comply. The FDA announced in April via their Guidance Document Providing...
May 1, 2018 | Foods, Issue of the Month
By Gustavo M. Gonzalez, Ph.D. So, you decided to have clean labels for your products, now what do you do? You are not alone in your pursuits of this endeavor. A couple of years ago, I was approached by a marketing department when they wanted to make certain claims in...
May 1, 2018 | FDA and USDA Regulatory Update
FDA released Guidance for Industry on highly concentrated caffeine in dietary supplements. FDA considers products which only or primarily consist of pure or highly concentrated caffeine and are sold as dietary supplements to be adulterated under section 402(f)(1)(A)...
May 1, 2018 | Who’s Who at EAS
Dawn Wydner, Ph.D., consults in pharma and medical devices, providing proactive compliance and application of quality oversight in all aspects of operational strategy, coordination and conduct. Prior to consulting she was the Senior Director of BioResearch, Quality,...
May 1, 2018 | Ask the Expert, Cannabis
By Kathy Knutson This month’s Ask the Expert is answered by Independent Consultant, Kathy Knutson, Ph.D. Kathy is a lead instructor for Preventive Controls for Human Food (PCHF); Preventive Controls Qualified Individual (PCQI) and trained in the prevention of...
