by Samme Jancin | Jun 17, 2015
The US Food and Drug Administration (FDA) recently published new guidance titled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.” This guidance was created to help the industry distinguish which changes to a pharmaceutical...
by Samme Jancin | Jun 15, 2015
After the 13th European- Genetic Association-European Biosimilar Group meet last week, it was recommended that to license a biosimilar, you do not necessarily have to perform a clinical trial in second indications. This is consistent with the current US and European...
by Samme Jancin | Jun 15, 2015
On June 10th, Australia announced that it has created a new way to gauge the performance of regulators. This framework is called the Cutting Red Tape and it sets out to reduce the costs of regulations for individuals and businesses in Australia. Not only has Australia...
by Samme Jancin | Jun 12, 2015
The Indiana Medical Device Manufacturers Council (IMDMC) is having an event to give those new to the medical device industry a background on FDA regulation. At the event, Pearl Pathways’ own, Gretchen Bowker COO & RAC will be presenting on, Pathways to Market. The...
by Samme Jancin | Jun 12, 2015
There have been mixed reviews on the recent publishing of three final guidance’s by the US FDA. Some reviewer’s support the release of these documents, while others fear the documents led to the risk of “taking a copycat product.” Two main groups that are concerned...
