Many drugs are approved with a boxed warning (BW) on their labels assuming that the prescribers and patients would make informed decisions about using these drugs. But how effective are they in this purpose? An FDA study to evaluate BW in prescription practices yielded interesting but unsurprising findings. A BW highlights serious risks associated with … Read more
De Novo classification requests require a significant investment of time and resources. Many applicants are new to the FDA regulatory processes and need help in putting together a reasonable request. In the last few years, the FDA has tried to help medical device submitters with application formatting via its eSTAR templates. This month they expanded … Read more
Participating in clinical trials is expensive and may be financially untenable, especially for economically challenged participants. Sponsors often offer compensation to trial participants to alleviate this financial burden leading to an unintended negative consequence; the participants owe taxes on the payments received and might lose their eligibility for government financial assistance programs. A bill in … Read more
In 2017, the FDA created its Competent Generic Drugs (CGD) program to encourage the development of generic versions for off-patent drugs with no competition. This was in response to a widespread practice in the industry where a monopoly for a product allowed the manufacturer of such drugs to gouge the prices of their product with … Read more
India is the source of many traditional, alternative, and herbal medicines including Ayurveda, Unani, and Homoeopathy. Although these medicines are mostly sold in India, a significant amount is exported to the US; almost 25% of all traditional medicines exported from India are destined to the US. FDA is aware that while none of these medicines … 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
In 2017, the FDA created its Competent Generic Drugs (CGD) program to encourage the development of generic versions for off-patent drugs with no competition. This was in response to a widespread practice in the industry where a monopoly for a product allowed the manufacturer of such drugs to gouge the prices of their product with … Read more
India is the source of many traditional, alternative, and herbal medicines including Ayurveda, Unani, and Homoeopathy. Although these medicines are mostly sold in India, a significant amount is exported to the US; almost 25% of all traditional medicines exported from India are destined to the US. FDA is aware that while none of these medicines … Read more
A couple of weeks back I speculated if we need an independent oversight of the FDA to rein in the seemingly unaccountable power its leadership holds over the industry it regulates. The same week, the US Supreme Court reversed a decades-old legal doctrine that gave government agencies, like the FDA, such power. There are divergent … Read more
While there have been numerous discussions by regulators worldwide, particularly the FDA and European Medicines Agency (EMA), about the regulation of devices based on Artificial Intelligence (AI), there have not been any specific rules, till this week. The EU published the first formal regulation for AI this week to lay down a uniform legal framework … Read more
