Regulatory Affairs

04
Feb

Don’t Reinvent the Wheel – Use Your SDLC Infrastructure to Manage Product Change Control

What engineer enjoys writing Software Development Life Cycle (SDLC) documents, such as a Software Requirements Specification or SFMEA?  I have yet to meet one that has the passion to sit and document the requirements. While there are numerous purposes and reasons for documenting the requirements, the greatest value is in the process that leads up […]

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02
Feb

No New FDA FR Notices Since the Inauguration!

We know that a regulation hold has been placed by the Biden Administration until they can review their positions on proposed regulations, but it is highly unusual that no FR notices have appeared since Inauguration Day, January 20, 2021.  Many FR notices address issues other than regulations, including meeting notices, guidance announcements, collections of information […]

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02
Feb

Medical Device and Drug Development and Manufacturing Data Governance in the Information Age

It is not uncommon for organizations to have different IT systems for regulatory, product, and organizational information.  Segregating the data, such as the QMS gate reviews, complaints, and adverse event reporting, from the product sales quota and organizational growth projections and actuals keeps regulatory auditors to the task at hand – inspecting the Quality Management […]

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01
Feb

Using AI to Modernize Diagnostic Tools

Machine Learning (aka Artificial Intelligence) has put a spotlight on the importance of algorithms.  While the term algorithm is ancient, meaning “a process or set of rules to be followed in problem-solving operations,” the modern use within refers to the complex way that the software behaves. Before broad adoption of Machine Learning in other industries, […]

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25
Jan

Compliance/Enforcement Activity, the Slow Down, and Predictions

Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry.  COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry.  High […]

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20
Jan
Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients Image

You Just Can’t Go a Week Without Seeing FDA Action on an ED or Weight Loss “Supplement”

So, here is my question – when will the Congress and the FDA get off their butts and do something about active pharmaceutical ingredients appearing in dietary supplements or the other issues with dietary supplements that occur over and over?  This is not a new problem.  We have posted about it numerous times here, here, […]

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19
Jan

Outlining COVID-19 Safety Expectations for ANDA BE Studies

On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”.  This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency.  As is no surprise, FDA clearly […]

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12
Jan
How did that happen?

So Now We Know Why the OMUFA User Fee Notice Was Withdrawn

The confusion regarding the initial publication of the OTC User Fee Act announcing the user fee structure originally published here and its subsequent withdrawal published here is (for the most part) clarified now by the January 12, 2021 FR Notice here that identifies the issue precipitating in the withdrawal. In the current FR Notice, the […]

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