Announcement this week of the recall of a batch of blood pressure medication from Accord Healthcare Inc (read the recall notice here) reminds us why Labeling and Packaging is one of the 6 critical GMP systems. The drug product (hydrochlorothiazide HCl, a commonly used...
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CDRH Seeks Advice from Experts and Consumers
On August 23rd, the FDA posted a request for nomination of individuals willing to serve on the public advisory committees for Device Good Manufacturing Practice and Medical Device subtypes. The agency seeks the help of technically qualified scientific and clinical...
Opportunity to Train CDRH Reviewers is Now Open
The Center for Devices and Radiological Health (CDRH) is now accepting applications from medical device companies, academia, and healthcare companies to host a site visit for CDRH reviewers (both new and experienced) to help them better understand patient needs and...
Are you ready for eCTD 4.0?
Companies who are using eCTD for submissions or developing eCTD tools should take note that the ICH M8 group completed an update to the ICH eCTD v4.0 Implementation Package during the ICH June 2018 meeting. The updated implementation package (v1.3) should be posted on...
How consensus data standards enable drug submissions at the FDA
Good data standards enable the effective sharing and comparison of scientific data. For example, the international drug regulatory agencies use a consensus standard called eCTD to help them receive, process, review, and archive submission data more effectively. Data...
The FDA is running out of 5 digit NDC codes
Example NDC codes The FDA has announced a public hearing on 4 approaches to gather comments on proposed changes to the current National Drug Code (NDC). The NDC is a 10- or 11-digit universal product identifier for human drugs in the United States, quickly identifying...
Birth Control for Millennial Women – Just Check your Phone
Last week’s FDA approval of Natural Cycles, a mobile medical app, makes available in the US a personal and discreet form of birth control that’s been available to EU women since August 2017. The app uses early morning temperature measurements logged by the user to...
The Future of RNAi Therapeutics is AntiAging
The FDA approved Onpattro last week, the first approved medicine to use small interfering RNA (siRNA) to prevent formation of disease causing proteins in the body. This class of therapeutics, known more generally as RNAi, is expected to create breakthroughs in the...