Represents a Shift in Thinking at the FDA The ECG app announced by Apple for the Series 4 Apple Watch has the potential to change how we think about and use our personal devices to improve our health and engage our healthcare providers. It also represents an important...
Uncategorized
Patient Focused Drug Development Guidance Workshop in October
The FDA announced a two-day public workshop to discuss Patient Focused Drug Development on October 15-16th at their White Oak Campus in Maryland. The meeting is being held to gather public feedback to create patient-focused drug development guidance as required by the...
Regulations, Procedures, and Guidance
Keeping Track of FDA Requirements for Medical ProductsThe FDA is a complex organization with a wide range of responsibilities in human and animal health and safety. Even when you know which office or center is responsible for a topic, the range of instructions...
Advisory Committees are One Way the FDA Gathers Public Feedback
Readers may not be aware that the FDA has a number of approaches to gather feedback on regulations, programs, and other proposed changes to how the agency operates. One of the ways the agency obtains independent expert advice on scientific, technical, and policy...
Electronic Submission Gateway
What It Is and Why We Need It Table of ESG Submission Types for Drugs and Devices The FDA’s Electronic Submissions Gateway (ESG) is a tool that facilitates the secure transmission of electronic submissions from industry partners to the agency. The Gateway is not part...
Medical Device Submissions Will Soon Be Entirely Electronic
This month the FDA proposed a new rule to remove the requirements for medical device premarket submissions to be made on paper with multiple copies and replace them with a requirement for a single submission in electronic format (known as an eCopy). As a bit of...
CDER Procedure Update
Establishing Limits for Impurities in DrugsCDER issued an update to MAPP 5017.2 R1 [revised 01MAY2020, updated link as of 09DEC2020] in September to clarify the review instructions for drug substance and drug product impurity acceptance criteria. The change...
FDA’s eSubmitter Software – A Tool to Help Prepare Submissions
The FDA offers a free software package called eSubmitter designed to help companies prepare electronic documents for selected regulated submissions (for example, CBER Annual Reports or CDRH eMDR reporting under form 3500A). The tool creates a package of documents on...