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As expected and promised, the FDA got sued this week for the new LDT Rule. In its latest attempt to regulate Lab Developed Tests (LDT), the FDA designated all such tests as conventional in vitro diagnostic (IVD) tests that require registration and formal approval or clearance by the FDA as a medical device. The lawsuit … Read more

Direct-to-consumer (DTC) advertisements for prescription drugs and biologics are important for creating product awareness among potential users/patients in the US and critical for their commercial success. Starting this week, a new rule for the tone and content of these advertisements has come into effect that requires these ads to meet five standards to ensure that … Read more

The scientists at the National Institutes of Health (NIH) US, the world’s largest government-funded research center, invent hundreds of new patented medical technologies each year that are licensed to industry partners for commercial development. NIH is proposing a change in its licensing terms to include additional commitments from the licensees for post-approval commercial activity for … Read more

Over the last year, numerous researchers have evaluated the potential of ChatGPT in healthcare applications from writing medical notes, to diagnostic decisions, prescription recommendations, and even medical consultations and research. However, ChatGPT is but one of the various large language models (LLMs) being evaluated in healthcare. And they all are in their infancy. ChatGPT has … Read more

Over the last decade, the FDA has repeatedly expressed strong interest in real world evidence (RWE) from real world data (RWD) in support of regulatory decisions but very few market approval applications significantly depended on RWE over the same period as shown in an independent review. It is critical to understand the reason for this … Read more

A study by the FDA aimed to evaluate which format of prescribing information would be perceived as more credible by physicians. Many times prescribers have limited time to make decisions about what prescriptions to write for their patients. With multiple options, the adequate presentation of prescribing information for drug products could significantly affect whether a … Read more

Clinical trials are the most expensive component of the overall cost of developing a new drug but there is little agreement on what a given trial should cost. Last month, Doctors Without Borders reported that it cost them $36 million to complete a 552-patient multinational trial indicating that the cost of the trials should be … Read more

A new guidance document released this week encourages sponsors of Phase 3 and post-market clinical trials to consider selective safety data collection (SSDC) whereby safety data is limited to major adverse events. The guidance will be hard to follow by the sponsors who are used to collecting detailed safety data in all trials, but does … Read more

As promised last year, this Monday FDA released the final rule formally eliminating the 30-year-old “enforcement discretion” for Lab Developed Tests (LDTs) by requiring all such tests to be formally regulated. The final rule contains critical timelines and clarifications and is accompanied by two new guidance documents. New LDTs will cease to exist immediately and … Read more

Recently, accelerated approval of drugs and other expedited approval programs have been questioned widely since they rely on limited pre-market evidence for approval and extended post-market commitments. It has been speculated that companies may not meet their post-market commitments in a timely fashion, if at all, and that the FDA may not enforce the post-market … Read more