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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
The European Ombudsman has accused EU regulators of blocking access to drug safety reports and other public documents in a new case that observers tell DID is part of the watchdog’s ongoing effort to bring greater transparency to the pharmaceutical industry. Read More
India’s drug regulatory authority has abruptly withdrawn a guideline for setting prices on many branded-generic drugs, a move that could help manufacturers press their case in a lawsuit against the government’s drug-pricing policies. Read More
Two New York congressmen have become the latest on Capitol Hill to question a proposed FDA rule that would give generics firms the same authority to change drug labels as brandmakers, a rule that GPhA has threatened to challenge in court if necessary. Read More
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