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TGA sought feedback on several potential changes to its biologics nomenclature, included introducing suffixes to biological naming conventions, similar to the FDA’s approach, or introducing barcodes to allow traceability of batches, similar to the European Union’s practice. Read More
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 adopt suffixes may offer little benefit for pharmacovigilance. Read More
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 applicant does not constitute a new regulatory hurdle. Read More
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. Read More
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 Economic Forum in Davos, Switzerland. Read More
The stay will be either until March 30, until the guidance’s early publication, or an announcement that the guidance will be published after March. Read More
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. Read More
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with trials that test the highest approved dosage rather than trials with multiple doses, the FDA said in new draft guidance for developing such products. Read More
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 inspections. Read More