As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and ...

This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, which can be found here and here, pertain to FDA actions on drugs ...

Beyond fielding an ever-increasing number of digital health clearances, the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape. The ...

The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies ...

The US Food and Drug Administration plans to go after homeopathic remedies that are unsafe for consumers and offer unproven benefits in the treatment of serious illnesses, such as cancer and asthma, ...

It’s been an exciting year for new drug approvals, with the FDA on a similar pace to the gangbuster year of 2015. Many of these new medicines address significant and meaningful needs, or offer ...

In 2017, the FDA approved 52 NTDs with combined projected peak annual sales of US$47 billion, substantially higher than the $32 billion in 2016 and somewhat above the longer-term mean of $40 billion ...

Please provide your email address to receive an email when new articles are posted on . Clinicians need to be aware of the contents of the June 3 memo from the FDA regarding use of human cell and ...

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