We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Acting FDA Commissioner Janet Woodcock told members of the Senate Committee on Health, Education, Labor and Pensions yesterday that the FDA was simply doing what the Congress had instructed when it granted an accelerated approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab). Read More
Developing a good working relationship with your regulatory project manager (RPM) at the FDA is “the single most important thing you can do” to improve communication during a regulatory review, an agency official said yesterday at the FDA’s Regulatory Education for Industry (REdI) Annual Conference. Read More
The FDA has denied Ardelyx’s new drug application (NDA) for tenapanor as a treatment for chronic kidney disease in adults on dialysis, citing concerns over the treatment’s effectiveness. Read More
Canadian generics manufacturer Apotex has agreed to pay the state of Texas $26 million to settle charges that the company reported inflated drug prices to the state’s Medicaid program for more than 30 years. Read More
New York state has reached a $1.1 billion settlement with three large drug distributors for their alleged roles in the opioid crisis, and a separate $26 billion settlement of thousands of related opioid lawsuits across multiple states is expected within days. Read More
The FDA has resumed routine domestic inspections this month after hitting the pause button for all but mission-critical inspections in March 2020, said Acting Commissioner Janet Woodcock yesterday on day-one of the FDA’s five-day Regulatory Education for Industry Annual Conference. Read More
An FDA inspection of Nostrum Laboratories’ Lenexa, Kansas facility found that it failed to properly identify and track bottles containing low pill counts after the company received complaints earlier in the year. Read More