FDA

FDA focuses on drug supply chain security

During the last year, the FDA has held a number of public meetings to focus on strategies and issues related to the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA). The DSCSA outlines critical steps to build an electronic, interoperable system by November 2023, to identify and trace certain prescription […]

FDA efficacy recommendations vary for hypogonadotropic hypogonadism drugs

New draft industry guidance from the U.S. Food and Drug Administration (FDA) underscores the importance of randomized, double-blind, placebo-controlled trials to establish the efficacy of drugs to treat male hypogonadotropic hypogonadism when it is caused by obesity or another acquired condition. The draft guidance also asserts the potential importance of patient-reported outcome (PRO) instruments to […]

Generics industry sets record for U.S. approvals, has ‘nothing to apologize for’

Download the full report. At the 2018 Association for Accessible Medicines (AAM) annual meeting, experts highlighted the generic industry’s recent accomplishments while noting that many challenges lie ahead. On the positive side for the industry, as noted by Jeff Watson, chairman, president and COO of Apotex, a controversial rule change regarding generic drug labeling in […]

FDA guidance recommends diversity in clinical trials for medical devices, but can’t require it

The FDA often stresses the importance of enrolling diverse patient populations in clinical trials conducted to support product applications — both in industry guidance documents and during interactions with product sponsors. In Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies, guidance released in September 2017, the FDA makes multiple […]

Modern tools to advance generic drug development and review

In news releases issued by the U.S. Food and Drug Administration (FDA), “firsts” always catch the eye. Because the majority of prescriptions in the U.S. are dispensed with generic medications, announcements of new “first generics” are especially noteworthy. These products are the first approval by the FDA that permits a manufacturer to market a generic […]

Everything old is new again: bacteriophage therapy

According to conventional wisdom, if you let children play in the dirt, they get sick less frequently. As is often the case, science appears to back up this homespun theory. Now that many disease-inducing pathogens are developing antibacterial resistance, scientists and medical professionals are looking for answers that may literally be beneath their feet. Bacteriophages […]

The impact of the changing regulatory environment on the approval of new medicines, 2007-2016

Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceuticals have resulted in more new active substances (NASs) being internationalized, referring here to receiving marketing authorization in six major regulatory agencies, namely the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the Japan Pharmaceuticals […]