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A federal judge in New Jersey ruled that a class of diabetes patients cannot sue insulin manufacturers under the Racketeer Influenced and Corrupt Organizations (RICO) Act because they did not buy the drugs directly from the manufacturers. Read More
The MHRA’s National Institute for Biological Standards and Control (NIBSC) released guidance in anticipation of a no-deal Brexit on March 29, including a flow chart biologic drugmakers can use to determine if their batches require UK certification. Read More
Canada has opted not to use four-digit suffixes in its naming conventions for biologics, making the United States the convention’s only adherent. Read More
Chairman Richard Neal (D-Mass.) said that Congress “will need to change policies and incentives in the FDA, CMS, and potentially even look in the tax code,” to address high drug prices. Read More
The FDA added six bulk substances to its list of substances approved for use by compounding facilities exempt from certain FDA oversight activities under section 503A of the Food, Drug and Cosmetic Act. Read More
The FDA released final guidance outlining the expedited pathways available to sponsors of regenerative medicine therapies — including considerations for clinical trial designs for treatments of rare diseases. Read More
FDA Commissioner Scott Gottlieb on Friday announced the release of draft guidance on a new approval pathway for generic drugs and said the agency will roll out new policies over the next year aimed at increasing access to generics and boosting price competition for branded drugs. Read More
In most cases, Pfizer said, the total content for a drug, including drug substance overfill, isn’t known because the amount of overfill is not normally posted in the USPI or other sources of public information. Read More
The defendants allegedly filled prescriptions for controlled substances outside of the course of professional practice and did not properly ensure that they were written for legitimate medical purposes. Read More