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CGMP Warning Letters

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - November 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Arnall Golden Gregory LLP

It Starts and Stops at the Top: FDA Issues Warning Letters for Lack of Corporate Oversight

The Food and Drug Administration issued two Warning Letters recently to pharmaceutical manufacturers where lack of corporate oversight was an issue. These Warning Letters reaffirm that senior management cannot delegate or...more

Arnall Golden Gregory LLP

Who Me? Yes, You. Couldn’t Be. Then Who?: FDA Reinforces That Contract Manufacturers Can’t Delegate Away Regulatory...

When my children were younger, we played a little game about “who took the cookie from the cookie jar” – Who me? Yes, you. Couldn’t be. Then who? We’d turn to another family member and start the game all over again. ...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | February 2018

FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more

Arnall Golden Gregory LLP

Labeling and Manufacturing Compliance for Dietary Supplements is About More than Avoiding Characterization as a Drug

We are all accustomed to seeing Warning Letters issued by the Food and Drug Administration for products marketed as dietary supplements that make claims that the Agency believes cause the product to be an unapproved new drug...more

Arnall Golden Gregory LLP

Get by with a Little Help from My Friends (Maybe Not): FDA Reiterates Reliance on Others Doesn’t Ensure Regulatory Compliance

Here we go again. The Food and Drug Administration issued a Warning Letter on December 13, 2017, to a Korean pharmaceutical company for non-compliance with current Good Manufacturing Practice requirements. What caught our eye...more

Hogan Lovells

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

Arnall Golden Gregory LLP

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good...more

Arnall Golden Gregory LLP

Anyone Can Enter Into a Quality Agreement, It's the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight

Many of us remember the classic comedy bit on the Seinfeld television show where Jerry was unable to secure the rental car for which he had made a reservation. He tells the agent: See, you know how to ‘take’ the...more

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