Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
The FDA hit Australian drugmaker Delta Laboratories with a warning letter for significant violations, including unreliable manufacturing processes, flawed stability testing and a lack of stability data. Read More
Wong Lap Kwong Medicine Company drew a warning from the FDA for failing to identify active pharmaceutical ingredients and to establish procedures for numerous basic functions in its Hong Kong facility. Read More