Companies need to consider all aspects of their relationship with prospective suppliers that could put them at risk for noncompliance with the FDA or increase the likelihood a poor quality…
Despite having an extra year before they must start submitting IND applications electronically to the FDA, companies should convert their IND process before NDAs and BLAs, in order to gain…
If sponsors expect to be ready to begin electronically submitting all applications by 2017, they must first build a framework for handling and retrieving documents and data in electronic form,…
Beginning in fiscal year 2017, drug and biologics makers must be ready to submit to the FDA in electronic form all documents related to new drug applications (NDA), biologics license…
The FDA will soon require drug and biologics makers to submit all new product applications in an electronic format. And within a few short years, the agency will stop accepting…
Companies want to develop the most effective electronic system possible to ensure efficient and reliable submission and acceptance of eCTDs.
Many companies that submit improper eCTDs either failed to learn the intricacies of what goes into a validated eCTD or didn’t adopt the necessary process changes.
When preparing documents for an eCTD submission, sponsors must ensure that all materials are properly formatted so that the review can start on time and proceed smoothly.
The Global Harmonization Task Force’s (GHTF) Study Group 1 has modified its definition of a medical device and provided an explicit definition for the term in vitro diagnostic (IVD) medical…
Devicemakers doing business in Malaysia must register their products, beginning in November, a Medical Devices Control Division (MDCD) official confirmed to IMDRM.