Last week, FDA published new guidance, Determining Whether to Submit an ANDA or a 505(b)(2) Application (CDER, 2019), to help Sponsors select the best abbreviated approval pathway for their product. While the guidance does not provide any monumental new initiatives, policies or...
Expertise: Consulting 227 results
To get a successful return on investment (ROI) for your product, it is essential to establish early in the process: Is there an unmet need for the product? Which attributes will the product need to access the market? Will providers...
One of the tenets of the FDA is to get safe and effective drugs to market as soon as possible. To expedite approval of products for which there is the greatest clinical need, the FDA offers four expedited programs to...
DURHAM, N.C., JULY 30, 2018 — Premier Research, a global provider of clinical development services to biopharmaceutical product innovators, has acquired Regulatory Professionals, Inc. (RPI), a California-based company that provides regulatory expertise and solutions to biotechnology, pharmaceutical, and medical device...
The overarching goal of the Special Protocol Assessment Draft Guidance for Industry May 2016 (HHS, FDA, CDER, & CBER) is to improve the quality of new drug applications (NDAs) and biologic license applications (BLAs) by providing more certainty in the clinical protocol...
A significant part of the FDA’s charge is ensuring the safety of drugs available to the public. While a substantial part of the FDA’s efforts in guaranteeing public safety go into the safety assessment process during drug development, the process...