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A Chicago jury found AbbVie not liable for an Arizona man’s pulmonary embolism that he blamed on AndroGel, the company’s testosterone replacement drug. Read More
The FDA updated its guidance to institutional review boards and clinical investigators, detailing its views on reimbursements for lodging and travel for clinical trial participants. 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Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA.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
The approval was based on two clinical studies with statistically significant reductions in treated bleeds compared to previous treatments with a bypassing agent. Read More
The FDA handed Mexican drugmaker Degasa a Form 483 with 12 observations listing the many noncompliance issues found during an inspection of its Jiutepec, Morelos facility, including faulty recordkeeping, inadequate testing and poor quality controls. 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