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Applications that use AI and machine learning (ML) have a unique dependence on data, said the FDA’s Digital Health Center of Excellence Acting Deputy Director MiRa Jacobs at Tuesday’s open forum held by the Alliance for a Stronger FDA. Read More
The FDA has released a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling and how, or if, the corresponding software function should be described in the prescribing information (PI). 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offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance on whether a single trial plus confirmatory evidence will suffice for a development program.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
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
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