Regulatory Affairs
Clinical and Regulatory Considerations for Developing COVID-19 Treatments – a Discussion with our Experts
Up Close and Personal with David Grégoire
David Grégoire joined Altasciences as Director of Quality Assurance in 2012.
ISSUE NO. 11 — Navigating the IND Submission Process
There are many challenges associated with early drug discovery and development.
The FDA Animal Rule and Standard for Exchange of Nonclinical Data (SEND)
ISSUE NO. 6 — Hybrid Medicines and 505(b)(2) NDA Approval Pathways
Hybrid medicines are drugs based on a generic molecule, and have a different route of administration, format, strength, or indication from the original reference product.
They require re-approval for market authorization, partly based
Will Biosimilars Replace Biologics?
Biologic drugs came on the market with the production of
What Effect Will the New NIH Policy Have On Multi-Site Research?
In June 2016, the National Institutes of Health (NIH) released a new policy on the use of a
FDA Issues Labeling Change for IR Opioid Medications
On March 22, 2016, the FDA announced that a labeling change will be required class-wide for immediate-release (IR) opioid medications prescribed for pain. According to their announcement, this change is a direct result of the FDA’s “continuing effort to educate prescribers and patients about the potential risks related to opioid use.”