• Regulatory NewsRegulatory News

    What FDA Can and Can’t Do to Help Lower Rising Drug Prices

    Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview. And sure enough, FDA doesn’t dip its toe into the pricing bog while deciding whether to approve or reject a new drug, and it also doesn’t negotiate with pharmaceutical companies over how to price drugs. But some FDA regulations do have a direct impact on drug prices, and with so...
  • Regulatory NewsRegulatory News

    Final Rule Allows FDA to Destroy Some Drugs Denied Entry into US

    As part of its efforts to protect the drug supply chain, the US Food and Drug Administration (FDA) is implementing a final rule that will allow it to destroy a drug valued at $2,500 or less that has been refused entry into the US under federal law. Background The final rule -- which is authorized by amendments made to the Federal Food, Drug and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act (FDASIA) -- comes as under existing rules, even if a...
  • India issues revised draft guidance for API exports to EU

    On 7 March 2013, India's Central Drugs Standard Control Organization (CDSCO) issued revised draft guidance on the "Written Confirmation" procedure that must be implemented by India's exporters of Active Pharmaceutical Ingredients (API) to the European Union. The procedure will also be required to be implemented by the CDSCO, including its port offices. Under EU law, the CDSCO has been designated as the "Competent Authority" for India and is responsible for notifyi...
  • Brazil: Anvisa Issues New Technology Transfer Regulation for Local Companies

    Local Brazilian companies will be the beneficiaries of a new technology transfer  regulation that is intended to reduce the country's dependence on foreign drug imports and technology.  The regulation, approved by the Board of Brazil's national regulatory agency, Anvisa, on 13 September 2012, establishes procedures for local companies to enter into drug development and technology transfer partnerships with the National Health Service (SUS).  The regulatio...