Generic drug manufacturers could face new regulatory requirements from FDA

FDA recently announced critically important information for all generic drug manufacturers which will require generic drug manufacturers to develop and implement safety-related changes to their labeling. If/when implemented, generic companies will have a paradigmatic shift in their role related to safety surveillance and labeling updates. Prior to this new rule generic companies could only change…

Types of FDA Drug Labeling

Generic Labeling Inconsistent with Reference Listed Drug 78% of the Time

A recent study found that 78% of generic drug labels are inconsistent with the labeling of the reference listed drug (Duke et. Al 2012). While most of the differences were relatively minor, nearly one in ten were off by more than ten side effects.  The researchers reviewed 9,105 labels representing over 1,500 drugs on DailyMed,…


FDA Announces User Fees for Drugs, Devices, Biosimilars

The FDA Safety and Innovation Act (FDASIA) contains 140 pages of changes to the pharmaceutical industry, including a pronounced change to User Fees for Published Drugs and Biosimilar Products. These changes may have quite an impact on your strategic development plans, which addressing sooner rather than later can have a effect on your bottom line. …

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…


As Expected, User Fee Bill Passes House Heads for Senate

The Food and Drug Administration Safety and Innovation Act (FDASIA) goes to the Senate for a vote next week after passing by a large margin in the House June 20. The new user fee legislation will result in a number of changes at FDA including generic user fees.  At the current pace, signature into law…