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Commonly prescribed generic drugs in Canada will see a price cut of up to 40 percent in April as part of a new initiative announced Monday by two drug industry groups. Read More
Drug sponsors seeking Qualified Infectious Disease Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA. Read More
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