Regulatory Affairs
From Lead Candidate to In-life Use
From Lead Candidate to In-life Use – Manufacturing Drugs from Formulation Development to Commercialization
Podcast Speakers:
Steve Schweibenz, President, Manufactur
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. With timelines, budget, and market competition being critical factors, advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials. Partnering with the right CRO early on can increase your chances of success and ensure you meet your milestones. In fact, we recommend initiating discussions with a CRO at least six months in advance to ensure that capacity, resource availability, and animal supply are built into your timelines.
In Issue 11 of The Altascientist, we provide a high-level overview of the preclinical component of your drug development program in preparation for regulatory submission, including:
- A submission checklist
- Pivotal toxicology studies
- Small molecules vs. biologics
- Considerations for before you begin (species selection, formulation, test article, bioanalysis, etc.)
- Small and large molecule timelines
- SEND data
- Selecting the right CRO for you
Preparing For Your IND Submission
Your IND application must contain information in the three following areas, as outlined by the U.S. FDA:
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.”