Editorial standards

Who writes our articles

Articles are written by the Alenvo team. Articles carrying a personal byline are written by that person, and each named author has a profile page with their background.

Articles bylined "Alenvo Regulatory Team" are written collectively by the team and published under Alenvo's name. Alenvo is accountable for everything it publishes.

How we source claims

We rely on primary sources wherever they exist: FDA guidance, the Code of Federal Regulations, FDA announcements and databases, and ICH guidelines. Sources are listed at the end of each article.

Worked examples that are not drawn from a public record are labelled as illustrative. Where a figure or date could not be confirmed against a primary source, we soften or remove the claim rather than state it as fact.

Dates and updates

Every article shows the date it was first published. When an article's content changes materially, we update it and show the date of that update. Minor corrections to spelling or formatting do not change the date.

Corrections

If you believe an article contains an error, please tell us through our contact page. We review every report and correct confirmed errors promptly.

Independence and scope

Alenvo is not affiliated with FDA or any other regulator. Our articles are general information on public regulatory requirements and are not regulatory or legal advice. Articles may close with a short note on how an Alenvo product relates to the topic; that note is always separate from the analysis.