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Brazil's Anvisa issued a rule on June 18 establishing criteria for the priority review of small molecule drugs and biologics. Rule No. 37 applies to marketing authorization, postauthorization and clinical study applications. Read More
Australian regulators are seeking industry input on the pilot phase of a new system that will let drugmakers submit applications electronically, as the country prepares to fully adopt the software next year. Read More
The FDA is explaining how generics firms can receive timely responses to their requests for information in a guidance that defines a new communications process known as “controlled correspondence.” Read More
The FDA is mulling changes to the way it determines eligibility for 180-day generic exclusivity, including opening up the exclusivity decision-making process to the public, and it’s inviting industry to offer feedback on the idea. Read More
Roche got the greenlight on Thursday to market its blockbuster cancer drug Avastin for the treatment of advanced cervical cancer, making it the first biologic drug approved in combination with chemotherapy for the disease. Read More
The FDA has been asked to turn over a trove of information related to the development of its proposed generic drug labeling rule, with GOP leaders of a key House investigative committee claiming the agency engaged in “dubious” behaviors in the rulemaking process. Read More
Companies exporting drugs from India were supposed to include barcodes featuring identification codes and serial numbers on all primary-level packaging by July 1, but the union government has postponed that date indefinitely. Read More
A New Jersey drug coating company hasn’t paid its generic drug facilities fees for the last two fiscal years, making every product it helps to manufacture automatically mislabeled, the FDA warned. Read More
Regulators in Canada are revising the dispute resolution process for drugmakers appealing rulings on drug applications, eliminating some available appeals categories and changing what body is responsible for reviewing the disputes. Read More
The FDA’s newly created four-point sliding scale of comparability between original biologic products and their biosimilars does not belong in guidance on data to demonstrate that similarity, PhRMA says. Read More