FDA recently published the final guidance document “Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” This final guidance provides recommendations to original applicants and holders of approved applications for human drugs and certain biological products …
The question of whether FDA has authority to take pictures during an inspection of a facility has bounced around the food and drug bar for many years. FDA’s view is stated in the agency’s Investigation Operations Manual, and it is one with which a number …
During last year’s 2021 Pharmaceutical Quality Symposium, CDER described the development of a regulatory framework called FRAME –Framework for Regulatory Advanced Manufacturing Evaluation, to accommodate innovation expected in the next 5-10 years with a focus on 4 technologies: End to End Manufacturing, Distributed Manufacturing, Point-Of-Care, …
Making use of real-world data has long been of interest to stakeholders as having tremendous potential value. These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the …
If you have purchased anything in recent months or kept up with economic reports, you are familiar with the unwelcome observation: “Prices have gone up!” That could not be more true than in the area of medical device user fees. Medical Device User Fees After the Congressional …
If, as Albert Einstein supposedly quipped, a cluttered desk is the sign of a cluttered mind, what then does a cluttered medicine cabinet signify? More than a mere sign, a cluttered medicine cabinet can be hazardous if it contains unneeded and expired prescription medication susceptible …
Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here). Amongst CDRH’s highest prioritized …
Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that James E. Valentine will become the firm’s newest Director beginning on January 1, 2023. James’s practice focuses on regulatory considerations for developing new drug and biologic products and FDA regulatory requirements for approval/licensure. James has been …
“We still have a problem with COVID. We’re still doing a lot of work on it. But the pandemic is over. If you notice, no one is wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing.” President Biden made …
While COVID-19 and monkeypox may be the public health emergencies garnering much of our current attention, we have been in the midst of another declared public health emergency for nearly 5 years: the opioid crisis. FDA recently issued a Guidance (Exemption and Exclusion From Certain …
As we begin the final quarter of 2022 and the leaves here on the east coast begin to turn and fall, it seems the clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of …
On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains …
On October 6, President Joe Biden issued a brief but sweeping three-step statement towards reforming Federal marijuana law. The president’s first step was a pardon of all prior federal offenses of simple marijuana possession and a direction to the Attorney General to develop an administrative …
On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls. Wilson Bryan opened this new forum for direct agency …
It is with great excitement that we share CDRH’s announcement that now anyone may submit premarket submissions directly to the Center through the Customer Collaboration Portal (CCP). We heard from a number of readers after our prior post (here) asking how they could get access …
