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“Skinny labeling” on 15 generic drugs saved Medicare an estimated $14.6 billion from 2015-2021, but patent lawsuits may threaten the practice, according to an analysis published in the Annals of Internal Medicine. Read More
Shouldering the cost of FY25 federal employee pay increases may cause the FDA’s Office of Regulatory Affairs (ORA) to reduce the number of inspections it can conduct, said the office’s Associate Commissioner for Regulatory Affairs Michael Rogers during an Alliance for a Stronger FDA webinar Wednesday. Read More
Most of the new oncology indications approved under Real Time Oncology Review (RTOR) relied on surrogate endpoints that were never confirmed as clinically effective in postmarketing trials, according to a research letter published in JAMA Network Open. Read More
A recent Warning Letter to www.dashpct.com, a Malaysian online marketer, should send a clear message that the agency is getting tough on companies selling unapproved and misbranded semaglutide (Rybelsus/Ozempic/Wegovy). Read More
In a punishing one-two punch, the FDA slammed Zydus Lifesciences for the second time this month, with a 10-observation Form 483 finding — among other things — inadequately investigated glass particulate in injected drugs found in US markets and multiple deceptions about routine sample collection for contamination testing. Read More
This edition of Quick Notes provides an overview of four recently released draft guidances on the manufacture of cell-based products and on the FDA’s enforcement policy regarding test manufacturers’ offering of certain unapproved tests during a future declared emergency or in the absence of such a declaration. Read More
The FDA is soliciting written feedback as well as presenters to speak on its use of and processes for its advisory committee during a virtual listening session scheduled for June 13. Read More
Big pharma again came out on the losing end of a major court battle challenging the Biden administration’s Inflation Reduction Act (IRA) drug price negotiations, as a New Jersey federal judge Monday rejected legal challenges from Bristol Myers Squibb and Johnson & Johnson. Read More