Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,
On the second day of AAM’s GRx-Biosims Conference, in Bethesda, Maryland, a session was held related to drug/device combination products. The session included several presenters from the FDA and industry. While the challenges with the drug/device combinations was well covered in the session, there wasn’t a lot of focus on the opportunities.
In an immediately effective guidance document entitled Compliance Policy for Combination Product Postmarketing Safety Reporting (here), the FDA is announcing that it will exercise enforcement discretion for certain safety reporting requirements outlined in the Combination Product Postmarketing Safety Reporting Final Rule issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR Part 4,
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,
Ricki Chase, Director, Compliance Practice, authored an article published in Medtech Insight, “How Device Makers Can Leverage FDA Data to Uncover The Agency’s Current Thinking on Compliance”. In this article, she discusses how manufacturers can use information available online from inspectional observations, warning letters, and product recalls to ascertain FDA’s priorities with regards to compliance and enforcement actions.
The DIA Complex Drug-Device Combination Workshop is being held at the Sheraton Silver Spring during October 9‑10, 2018. The first day of the conference dealt with the regulatory aspects of the generic submissions for these kinds of products, and discussions on clinical aspects related to complex generics, with a focus on inhalation products.
The meeting was well-attended,