This week, FDA’s Commissioner made a detailed announcement about regulation of adult stem cells which caught everyone’s attention but it lacks specifics and does not indicate a change in the existing rules for the regulation of stem cell clinics. Adult stem cell therapies are available freely in the US from hundreds of providers. There are … Read more
In a new guidance document released by FDA practically every party that is involved in any aspect of the manufacture, distribution, shipping and handling of drugs and biologics will be required to register either with the FDA directly or with a state regulators where they operate. Several new parties are added to the registration requirements … Read more
DTC ads using social media are essential for marketing of a new drug and celebrity endorsements are a necessary component of it, particularly if the target population is broad. A company can reach a much wider audience using a recognized name. However, these endorsements frequently cross the fine line between FDA allowed communication and off-label … Read more
In JAMA this week, an article raises doubts about the safety and effectiveness of drugs approved by FDA via the accelerated approval program but a critical review shows that despite the concerns raised, the regulatory pathway does its job as intended. Drugs and biologics intended for life-threatening or serious conditions can be approved based on … Read more
An article in the New York Times this week discusses something that all sponsors of cancer trials know too well; there are not enough patients in the US for clinical trials with new drugs. One out of three active clinical trials or about 6300 trials currently recruiting patients in the US are for anti-cancer drugs. … Read more
The manufacturing process for any given FDA-regulated product could go through several changes, each of which needs to be reported to the FDA on a schedule based on the scope of the change. Manufacturers play it safe by sending most changes immediately which clogs the FDA reviewers’ time. This week FDA released a guidance to … Read more
Last week we discussed FDA’s revolutionary update to software regulation, namely establishment of a pilot pre-certification program for software developers with demonstrated high quality operations. This week FDA released its first guidance on the pre-cert program, in a question and answer format, further clarifying how the pre-cert pilot will work. The pre-cert program is open … Read more
About two years ago, in 2015, FDA launched an automated system for importers to submit shipment information for custom and FDA clearance and it has almost tripled the number of shipments that are cleared within minutes of arrival at the US ports allowing inspectors to quickly find the riskier shipments and focus their resources on … Read more
Last week FDA announced one of the biggest reshuffle in its policies for regulating software that should drastically reduce pre-approval regulatory burden on the developers and focus resources on evaluation of post-market consumer use data. FDA will change its traditional process for software as a medical device (SaMD) and use a revolutionary new approach to … Read more
This week FDA announced several initiatives aimed at greater patient engagement in regulatory processes that could greatly affect future approval decisions and other regulatory actions by the Agency. Involving patients in regulatory processes humanizes the regulatory process by educating consumers about how the FDA works. At the same time, it provides the FDA reviewers first-hand … Read more
