Home

Latest Discussions

  • You can use the word therapy if it is part of a cosmetic claim: like therapy to smooth the skin or therapy for dry skin. Be careful that permanent claims are avoided. David Steinberg, FRAPS President SteinbergAndAssociates.net Office: 609-799-1575 Fax: 609-799-5271 ...

  • Hi Mark, I believe your comments are quite on point. FDA certainly has the statutory authority to pursue enforcement regarding marketing materials that are offending to the FD&C Act, but not to proactively investigate the internal procedures that companies use to develop and approve those materials. FDA has had a poor judicial track record ...

  • Dan, I agree wholeheartedly with this approach. In my current position, the previous regime referenced the ISO and FDA QS in EVERYTHING. It has been quite a task to remove them unless the reference is specifically, not generally relevant. Even then there is the consideration as to whether the revision is appropriate. I would prefer to have ...

Rainer Voelksen, FRAPS, Talks Volunteering and European Advisory Committee

"Regulatory professionals need to hear the voices of those working in other countries. Just helping others to get used to hearing other languages is important, and you can be a cultural representative at the table in any stage of your career. The regulatory industry is increasingly global, but all regulators work differently. We must all work harder to become comfortable sharing information in an international space so that the industry can successfully continue to develop."

Rainer Voelksen, FRAPS

 

Most Active Members