Safety report for serious adverse events (SAE) observed in bioequivalence/bioavailability (BA/BE) studies are submitted as FDA MedWatch Forms (FDA 3500A Form) to the FDA. Going forward, FDA requires that sponsors of BA/BE studies submit SAE reports electronically via the ESG or the Safety Reporting Portal (SRP) only. The purpose of such reporting is to make … Read more
An independent review found many errors about the start and completion timelines for clinical trials reported on the clinicaltrials.gov registry. It also found that NIH and FDA have no mechanism to police the inaccuracies in the reported study timelines. The errors primarily emanate from the lack of standardization of the definition of the start and … Read more
FDA’s practice of remote inspections, necessitated by the pandemic, is being made permanent via a new Guidance Document released this week. Remote inspections are known by many synonymous terms such as Remote Regulatory Assessment (RRA), remote interactive evaluations, remote record review, etc. Although FDA says that the RRAs do not replace on-site in-person inspections, and … Read more
Applicants must respond to a Complete Response Letter (CRL) within 1 year unless an extension is requested prior to the expiration of the 1-year period. So far, FDA liberally granted extensions for the CRL responses, but not for long. In a new guidance document describing a previously unenforced policy, FDA announced that it would limit … Read more
The Instructions For Use (IFU) provide critical information on how to use or administer a drug or biologic product for a patient or caregiver. FDA expects the IFU to be written in a simple non-technical language, in active voice, with size 10 or above font preferably Arial or Verdana, avoiding shading or highlights and many … Read more
While electronic submissions for drug and biologics applications have existed for more than a decade, medical device applications still get submitted as printed submissions and electronic copies that must be physically delivered to the FDA headquarters near Washington DC. Finally, this week, FDA started accepted truly electronic submissions for medical device applications and the process … Read more
For patients with untreatable serious or life-threatening diseases, the benefit of compassionate use or expanded access programs is indisputable. However, companies providing drugs to patients under these programs can also use these as opportunities to generate valuable real-world data in support of their regulatory applications. A report by Novartis’ compassionate use program recommends three steps … Read more
FDA approved drugs that have none or few generic versions are designated as Competitive Generics with special incentives to developers under a law passed in 2017 aimed to avoid monopolies that lead to price gouging. Manufacturers based in India dominate the development of competitive generis with almost 55% of all such generics developed by Indian … Read more
When the Regenerative Medicine Advance Therapy (RMAT) designation was proposed in 2016, it was assumed to be an easier expedited approval pathway specific for stem cells and other regenerative therapies, compared to the Breakthrough Therapy (BTD) designation. But it with about 40% approval rates and only 3 approvals, it may be turning out to be … Read more
Manufacture and distribution of drugs and biologics involve various parties with diverse responsibilities, and it was always confusing as to what regulatory requirements apply to them, till now. Who needs to register with FDA, who needs to pay fees, who needs to be licensed by other authorities, etc.? This week, FDA’s newest Guidance Document list … Read more
