In an announcement made April 24, 2017 Health Canada reaffirmed its intent to transition all regulatory submissions over to eCTD format.
Starting January 1, 2018 all New Drug Submissions (NDSs), Supplemental NDSs (SNDSs), Abbreviated Continue reading
In just a few days, May 5, 2017, the FDA will only accept eCTD formatted submissions for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs). Passing this milestone Continue reading
The introduction and acceptance of electronic submissions as the preferred submission process has been adopted at varying rates by different jurisdictions within the three ICH regions over the past several years. This move to provide a harmonized format has Continue reading
The EMA has released a new finalized guideline called Similar Biological Medicinal Products which introduces the main concept of the “possibility for drug product developers to use comparators authorized outside the European Economic Area (EEA)” during clinical development of biosimilars.
The new guidance Continue reading
Happy Holidays to our clients, friends, and family – wishing you a safe and enjoyable winter season.
As we welcome in the holidays we say goodbye to a phenomenal year that saw Regxia go through several pivotal changes that have allowed us to grow and strengthen our commitment to serve our clients.
This past year, we Continue reading
The US Department of Health and Human Services Department (DHHS) proposed a new rule with respect to Clinical Trial Registration and Results Submission. This proposed rule Continue reading
November 7, 2014. Another client has completed Learn@Regxia’s ICH GCP online training webinar, and we have received more great feedback! Continue reading
FDA has released two draft guidance documents on refuse to receive ANDA submissions. The purpose of the guidances are to help applicants prepare “ANDAs and PASs to ANDAs for which the applicant is seeking Continue reading
On October 23, 2014, Health Canada released a new Drug Establishment Licence (DEL) Application Form (FRM-033) with instructions. This form supersedes the Continue reading
The world and the African continent in particular are currently experiencing the worst Ebola virus disease (EVD) outbreak in modern history. With more than two thousand deaths estimated due to the Continue reading