The FDA is requesting all NDA and ANDA holders to submit a one-time, written status report to the agency after reviewing the information published in the Orange Book. Source: Drug…

The FDA finalized its May 2015 guidance on how makers of immediate-release, solid, oral products can request waivers for subsequent in vivo bioavailability and bioequivalence studies. Source: Drug Industry Daily

Sens. Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) asked FDA Commissioner Scott Gottlieb in a Dec. 18 letter to clarify the agency’s policies on importing prescription drugs from Canada. Source:…

Faster approvals of generics and biosimilars, along with other measures aimed at reducing prescription drug prices, will be ongoing FDA priorities in 2018. Source: Drug Industry Daily

In this issue of Drug Industry Daily, we examine some of the FDA’s priorities for 2018 and what industry experts expect to happen. We already know the FDA’s priorities for…

In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in…

The FDA hopes to bolster its scientific staff in 2018 — not only to expedite product reviews, but to meet its commitments to industry under the user fee agreements —…

The FDA’s use of real-world evidence in regulatory decision-making and further implementation of the 21st Century Cures Act are the biggest trends in clinical trials to track in 2018, according…

Quality experts and FDA officials predict 2018 will bring more streamlined FDA inspections and a greater focus on digital records and data integrity, as the agency implements its ambitious Concept…