In this second of our two-part series, we continue our discussion about significant recent developments regarding the regulation of ophthalmic products and discuss what to expect in the months ahead. Unsurprisingly, the U.S. Food and Drug Administration’s (FDA) released updated...
Expertise: Consulting 206 results
The global ophthalmic drugs market size was valued at $33.81 billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030[1]. Given this trend, many biopharmaceutical companies are investing in strategies to develop and commercialize new...
Consulting
Transitioning to eCTD v4.0
Almost 15 years after its last update, the Electronic Common Technical Document (eCTD)’s latest version has been finalized and is being rolled out internationally. eCTD v4.0 offers significant advancements in the way that sponsors and regulatory bodies handle submissions, and...
President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to...
Selecting the right CRO partner is a critical factor in the success of any cell and gene therapy (CGT) program. With global reach and deep therapeutic expertise, Premier helps navigate complex regulatory and development landscapes—reducing risk and accelerating timelines in CGT...
As a prerequisite for marketing approval, regulatory agencies typically require that a sponsor conducts a randomized controlled trial, where the control group is either a placebo, an active control, or a standard of care control arm.
For researchers who are developing or working with analytical procedures, the new ICH Q14 Analytical Procedure Development and revised ICH Q2(R2) Validation of Analytical Procedures drafts represent foundational guidance documents. Together, they describe suggested development and validation activities for the...
For researchers who are developing or working with analytical procedures, the new ICH Q14 Analytical Procedure Development and revised ICH Q2(R2) Validation of Analytical Procedures drafts represent foundational guidance documents. Together, they describe suggested development and validation activities for the...
Is your New Drug Application (NDA) submission on track? Throughout our years supporting FDA submissions, Premier Research has seen firsthand that many NDA and BLA filing delays are not caused by the submission itself, but by critical activities that begin...
On November 1, 2022, the U.S. Food and Drug Administration (FDA) adopted an addendum to the guidance titled “S1B(R1) Testing for Carcinogenicity of Pharmaceuticals,” which had previously been finalized by the International Council for Harmonization (ICH). The guidance document and...