An Australian Therapeutic Goods Administration proposal to expand the information offered in its current naming system for biologics drew support from most respondents, with Mylan warning an alternate proposal to…
A federal judge ruled that the FDA’s denial of exclusivity of a generic version of Namenda XR was lawful, writing that the agency’s request for more information from an ANDA…
A District of Columbia court partially ruled against Amgen in a dispute with the FDA over what the company called inconsistent agency approvals of pediatric exclusivity. Source: Drug Industry Daily
FDA Commissioner Scott Gottlieb spoke about the regulatory challenges of precision medicines and the agency’s plans to focus on durability and safety issues, in a panel discussion at the World…
The FDA hit Australian drugmaker Delta Laboratories with a warning letter for significant violations, including unreliable manufacturing processes, flawed stability testing and a lack of stability data. Source: Drug Industry…
The FDA filed a joint motion with Endo to pause the company’s lawsuit accusing the agency of breaking the law with its decree authorizing bulk compounding of drugs. Source: Drug…
Drug sponsors can prove the effectiveness of combination drugs for treatment of hypertension with trials that test the highest approved dosage rather than trials with multiple doses, the FDA said…
The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities and adopting a more flexible, risk-based approach to how often the agency will conduct…
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorizations for 92 drugs and biologics in 2017, an increase from 81 in 2016 but down from…
Drugmakers must do more to ensure access to treatments for antimicrobial-resistant superbugs, but GlaxoSmithKline and Johnson & Johnson are doing more than other organizations on 16 metrics of progress, according…