Expertise: Consulting 225 results
Throughout our years of preparing and filing Food and Drug Administration (FDA) submissions, Premier Research has often encountered sponsors who cannot file a New Drug Application (NDA) or Biologic License Application (BLA) within expected time-frames, most commonly due to a...
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...
The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children. PREA requires new drug...
Small- to mid-sized biotech and pharma companies face many challenges when planning and executing an early-phase oncology trial, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints. For...
Digital health products are widely used for the prevention, diagnosis, treatment, and management of health and disease. The introduction of digital medicines—and, more recently, digital therapeutics (DTx)—has begun to influence the treatment and management of certain diseases, both by consumers...
Computer modeling and simulation of humans, both healthy and with diseases, is a powerful tool. It can augment preclinical and clinical research through mechanistic and predictive investigations that would otherwise be impossible. In recent years, regulatory agencies have begun to...
Many 505(b)(2) development programs have been placed on clinical hold or otherwise disrupted because of incorrect or inadequate advice from professionals inexperienced in 505(b)(2) product development. Companies that have historically developed products through 505(b)(1) NDAs or ANDAs may not be...
One of the most common formulation issues that sponsors of new drug or biologic products face is the qualification of novel excipients. Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA)...
Research and development (R&D) investment decisions may be the largest risk taken by drug developers. When a single asset has broad applicability, sponsors must perform a thorough evaluation of its scientific, regulatory, clinical, patient, and commercial elements to determine the...