FDA Regulations Seminar- Free Admission

You and your team are invited on Thursday, December 12, the SFMA’s Regulatory Affairs and Quality Committee will be hosting its first seminar titled: To Be or Not to Be? (Register now) Looking forward to seeing you there to share our knowledge and regulatory concerns...

Transdermal and topical delivery systems – NDAs and ANDAs

FDA announced today the availability of draft guidance for industry entitled “Transdermal and Topical Delivery Systems – Product Development and Quality Considerations.” This guidance provides recommendations to applicants and manufacturers of transdermal...

Open Positions at our Puerto Rico Office

Lean Enterprise Consulting, Assisting Companies to Unleash Human...

SFMA & FDA Invites you !

On Thursday, December 12, the South Florida Manufacturers Association and it’s Regulatory Affairs and Quality Committee will be hosting its first seminar titled: To Be or Not to Be Regulated? The Food and Drug Administration (FDA) regulates both finished dietary...

Be aware if you buy OTC drugs at Dollar Tree stores

FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs...

Failing in the most basic cGMPs

  UPDATE on angiotensin II receptor blocker (ARB) recalls – FDA warns Mylan for CGMP deviations Today, the U.S. Food and Drug Administration posted a warning letter to Mylan Pharmaceuticals, Inc. in Chodavaram Village, Vizianagaram, Andhra Pradesh, India. Mylan...