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Drug sponsors applying to include products on the Australian registry should submit both favorable and unfavorable information with their nonclinical study reports, according to amended guidance. Read More
The FDA said it plans to create a central database with information on how different parties experience risk evaluation and management strategies, a project that is part of the agency’s effort to improve communications around REMS requirements and activities. 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
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
The National Institutes of Health is asking pharmaceutical manufacturers, wholesalers and repackagers to submit samples of their pills as part of an ongoing push to better identify drug products. Read More
Two FDA advisory panels last week overwhelmingly recommended the agency not approve Clarus Therapeutics’ Rextoro testosterone replacement therapy. Read More
The FDA is moving to ease industry fears that ANDAs filed after September of this year will receive priority over earlier applications simply because they were filed before the law required the agency to assign review deadlines to new applications. Read More
A new bipartisan House bill would stop brandmakers from relying on a drug-control program to deny generics firms the batch samples they need to put together an ANDA. Read More
GlaxoSmithKline must pay a fine of roughly $490 million and change its business practices in China after a Chinese court found the company guilty in a year-old bribery case. Read More
The UK’s health-cost watchdog said it’s not ready to change the way it appraises medicines and other technologies, but acknowledged that further consideration is needed on how new treatments are developed, evaluated and supported for adoption in the National Health Service (NHS). Read More
Generics makers with first-to-file ANDA status say they are frustrated by the FDA’s slow approval times, claiming their 180-day market exclusivity period is jeopardized by agency inaction. Read More
The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, say generics makers, that laid out a variety of other shortfalls they see in the agency’s generic drug approval process. Read More