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Indian authorities are reminding clinical investigators that trial applications must include information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product and existing options. Read More
Sponsors submitting plans to test drug products in children in Europe need to provide the European Medicines Agency with information on all formulations being developed, according to final guidance published Sept. 27. Read More
Companies developing pediatric vaccines for diphtheria, tetanus and pertussis, or DTaP, can streamline the process by using a single dosing schedule in clinical trials, new guidance from the European Medicines Agency says. Read More
A European biotech association is calling on EU regulators to develop new guidance on the labeling of biosimilars that will end the practice of assigning a generic label to the complex products. Read More
The FDA expects to have standardized formats for ANDA data submissions in place and required for all filers by the first half of fiscal year 2017. Read More
Better postmarket surveillance of generic drugs and a greater understanding of the bioequivalence of hard-to-compare products will top the FDA’s regulatory science priorities under GDUFA in the new fiscal year, the agency said. Read More
Canadian regulators plan to ratchet up scrutiny of patent litigation settlements between brand and generic drugmakers in search of antitrust deals that delay generic competition. Read More
FDA officials sought to clear up questions about what standards the agency will apply when approving biosimilars, emphasizing that manufacturers must prove their products are “highly similar” to the reference product in order to win a green light. Read More
A pair of lawmakers has launched a congressional investigation into dramatic price increases on some generic drugs, but GPhA dismisses the scrutiny as being so narrowly focused that it misses the overall savings from the industry as a whole. Read More