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
The FDA made a public announcement this week asking consumers to not use anti-chocking devices, saying that they are not effective and that manual anti-choking procedures are much better. Anti-choking devices are popular, particularly with parents trying to be prepared for accidental choking of their children. However, the lack of FDA enforcement highlights the limits … Read more
Eli Lily has been trying to rein in compounding pharmacies from selling compounded versions of its super blockbuster anti-obesity drugs for more than a year now, unsuccessfully, and in the process establishing precedence for the rights of such unauthorized legal versions of approved drugs that would have an impact on other similar scenarios. Compounding pharmacies … Read more
Since the publication of the Critical Path Initiative over two decades ago which included smart trial designs, the FDA has introduced several innovative clinical trial designs to improve clinical trial conduct and expedite new drug developments. However, the adoption of those non-conventional designs has not yet become mainstream. Most clinical trials still follow traditional designs … Read more
New Dietary Ingredient (NDI) registration has been required for almost 30 years but the regulations for such registration are one of the hardest to enforce and frequently less understood. There are many perceptions, right or wrong, about the definition of an NDI, the contents of the application for registration, the FDA review process, and other … Read more
