Drug Master File

November 9, 2013

Drug Master File

The information contained in the Drug Master File (DMF) may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments and supplements to any of these. The US DMF contains factual and complete information on a drug product chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.
February 9, 2013

Combinations of Medical Devices with CE Marking

According to CE Marking MDD article 9.1 and the “Essential Requirements” in annex 1 of the Directive 93/42/EEC, when a medical device is intended for use in combination with another medical device or other equipment, the combination, including the connection system, must be safe, and must not impair the specified performance of the individual devices. To ensure safety when putting into service and during use, article 13.6.c and annex 1 of CE Marking Directive 93/42/EEC […]