Dietary Supplements and New Dietary Ingredient Notifications (NDINs)
FDA Issues Final Guidance on Updated Procedures and Timeframes
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Tag: FDA News
FDA Medical Device Establishment Registration
FDA Proposes Modifications to Medical Device User Fee Small Business Qualification and Certification
A Game of Red Light, Green Light: A Look at FDA Import Alerts
The dreaded “Red List” and “Black List” (even the colors and short-form names spark fear!) commonly refer to FDA’s enforcement tool, “Import Alert”, an FDA-directive that is intended to inform the FDA’s field staff and the public that the FDA has enough evidence or other information to allow for “automatic detention” or “Detention Without Physical […]
Heads Up Medical Device (and Cosmetic Device) Manufacturers and Importers!
FDA Makes Changes to Device GMPs to Align More Closely with International Consensus Standards.
What’s Coming Down the Pike for Foods and Cosmetics, you ask?
FDA Showcases New Regulation Portal for Food + Cosmetics Program
MoCRA Readiness
What Should I Really Be Doing Now to Tone and Brighten for FDA Cosmetics Compliance?
How to Initiate and Execute an FDA Recall
Quickly Remove Potentially Violative Product and Minimize Business Disruption and Loss
An Early FDA Holiday Present!
FDA (FINALLY) Announces Opening of Cosmetics Direct Portal for Electronic Registration and Listing of Cosmetic Product Facilities and Products
FDA Revisiting Classification of Wound Dressings and Liquid Wound Washes
Last week, FDA proposed two new rules to classify certain unclassified, wound dressings and liquid wound washes containing antimicrobials or other chemicals into three separate classification regulations: Solid wound dressings: this covers products intended to cover and protect a wound against external contamination, to absorb exudate and to maintain appropriate moisture balance within the wound […]
A Sprinkle of Holiday (Lead-Free) Cinnamon Spice?
FDA Screens Incoming Shipments of Cinnamon for Lead Contamination as a Result of Recalled Apple Cinnamon Fruit Pouches.
★★★★★
Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.