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Gottlieb said the FDA will host a meeting with senior representatives and CEOs of internet stakeholders, in addition to academics and advocacy groups, to identify solutions. Read More
The Chinese government unveiled a new policy whereby some generics manufacturers could qualify for a “high-tech enterprise” designation, making them subject to a 15 percent corporate tax rate compared to the 25 percent rate paid by other companies. Read More
The FDA requested stakeholder feedback on its 2003 guidance on exposure-response analyses — prompted by PDUFA VI provisions on advancing model-informed drug development. Read More
India’s Central Drugs Standard Control Organization is creating a national database of pharmaceutical manufacturers, and will require reporting of facility and product details for inclusion in the database. Read More
A lawsuit from the federal government and 31 states accuses McKesson Corp. of repackaging “overfill” cancer drugs and fraudulently billing federal and state governments. Read More
Manufacturers should include all components including drug substance, lipids, nonlipid components of the liposome and all nonliposome inactive ingredients. Read More
The company asked a federal judge to force the plaintiffs to take their antitrust cases to arbitration, citing an arbitration clause in its distribution agreement. Read More
Internet service providers, social media companies, and other prominent members of the Internet economy need to help identify and remove illegal offers to distribute opioids, FDA Commissioner Scott Gottlieb said at the National Rx Drug Abuse and Heroin Summit in Atlanta, Georgia. Read More
The National Institutes of Health launched a new initiative to address the opioid crisis, increasing funding for research on opioid misuse, addiction and pain from approximately $600 million in fiscal year 2016 to $1.1 billion for fiscal 2018. Read More