eCTD Update

A Regulatory Affairs Consultant’s eCTD Update

According to the Regulatory Affairs Professional Society (RAPS), the “The eCTD has become the standard for many regulatory agencies around the world.” FDA’s CDER and EMA have mandated eCTD specifications for all electronic submissions. FDA is forecasting mandates for electronic-only submissions for Abbreviated New Drug Applications (ANDA) and type II Drug Master Files (DMF), Biologics License…

Recent FDA Presentation on Advertising, Promotional Compliance, Social Media Helpful and Informative

Recently, representatives from PDG attended the second meeting of the Central Florida chapter of RAPS. Featured was a presentation by Leo J Lagrotte, Consumer Safety Officer, Food and Drug Administration (FDA), FLA-DO/TMP-RP entitled “FDA Perspective on Advertising and Promotional Compliance and Social Media”.  Mr. Lagrotte’s patient and thorough explanation of topics such as solicited vs.…

PDG to Attend RAPS Florida Chapter Meeting

Those of you who will be in central Florida this week are welcome to join PDG at an FDA presentation by Leo J Lagrotte, Consumer Safety Officer, Food and Drug Administration (FDA), FLA-DO/TMP-RP entitled “FDA Perspective on Advertising and Promotional Compliance and Social Media” on May 24th, 2012, 5:30–8:30 pm at the Hampton Inn and…