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The best way to design trials around an artificial womb intended to better regulate body temperature and foster safer lung development in extremely premature infants (EPI) is the focus of the FDA’s Pediatric Advisory Committee (PAC) as they meet on Tuesday and Wednesday of this week. Read More
Focusing on fostering a culture of quality in a drug manufacturing company seems obvious today — a given. But that wasn't always the case, explained industry veteran Sue Schniepp, a distinguished fellow at the consulting firm Regulatory Compliance Associates. Read More
The FDA has offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance on whether a single trial plus confirmatory evidence will suffice for a development program. Read More
GSK’s Ojjaara (momelotinib), the first and only treatment for myelofibrosis patients with anemia regardless of prior myelofibrosis therapy, received FDA approval on Friday. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
The FDA released two draft guidances for biosimilar manufacturers — one on labeling that focuses on prescribing information and the other on the FDA’s licensure requirements. Read More
To combat allegations of political interference — which may have impacted HHS’ response to the COVID-19 pandemic — HHS agencies, including the FDA, are updating their scientific integrity policies and implementing new safeguards to protect against such interference, says a new report from the Government Accountability Office (GAO) issued Thursday. Read More
In the latest in an ongoing dispute, CDER has strongly rejected Oncopeptides’ appeal of the agency’s attempt to request the drugmaker withdraw its multiple myeloma therapy Pepaxto (melphalan flufenamide). Read More
Over the past week, the FDA issued final guidance on IRB review of individual patient expanded access submissions, postmarketing requirements and commitments, the Breakthrough Devices Program and the medical device Voluntary Improvement Program. Draft guidances were also issued on clinical and non-clinical studies of weight loss medical devices. Read More
The FDA’s work with cancer drug manufacturers has brought the cisplatin supply back to nearly 100 percent of the pre-shortage levels, the White House said in an announcement on Tuesday. Read More
On Thursday, the FTC voted unanimously (3-0) to issue a policy statement warning pharmaceutical companies that they could face legal action for improperly listing patents in the FDA’s Orange Book in an attempt to stave off competition. Read More
This special edition of Quick Notes covers FDA issuance of final guidance for the Breakthrough Device Program, drug postmarketing requirements and commitments and the CDRH voluntary improvement program as well as draft guidances on clinical study design and non-clinical testing of weight loss devices. Read More