The European Medicines Agency’s (EMA) initiative to share agency assessments reports, aims to facilitate the timely authorization and availability of safe, effective and high quality generic medicines in support of the International Generic Drug Regulators Pilot (IGDRP), and has now expanded to include regulatory agencies worldwide.
The IGDRP was created in 2012 to 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
FDA has released two draft guidance documents on refuse to receive ANDA submissions.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
The International Generic Drug Regulators Pilot (IGDRP) was created in 2012 to promote collaboration and convergence in generic drug regulatory programs in order to Continue reading
Health Canada has released a consultation document regarding drug submissions relying on third-party data (literature and market experience). The guidance applies to Continue reading
In order to provide industry with guidance on how to meet the BA and BE requirements as they apply to dosage forms intended for oral administration the FDA has published this draft guidance for general considerations. The guidance applies to Continue reading
On February 19, 2014, the FDA announced its revised draft guidance for industry entitled “Analytical Procedures and Methods Validation for Drugs and Biologics”. The 2014 draft guidance will Continue reading
While the FDA’s public comment period on the recently proposed rule aimed at creating parity between ANDA (generic drug) holders to revise product labeling has expired, the literature regarding the implications of this proposed rule is still being produced. Continue reading
In an effort to ensure patient safety and compliance to medication requirements to prevent medication error, the FDA has issued this draft guidance on Size, Shape, and Other Physical Attributes of Continue reading