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Tag: FDA News
Using AI Tools in FDA Compliance
Power, Pitfalls, and the Non-Negotiable Role of Human Review
The FDA Called. They’d Like to See Everything
FDA inspections don’t arrive with much ceremony. There’s no buildup—just a badge, a few introductions, and then a steady stream of questions about your documents, your systems, and your people. What has changed is everything around that moment. Inspections are happening more often, follow-ups are quicker, and tolerance for “we’ll fix it later” has narrowed […]
MoCRA in Practice
How FDA Is Implementing Its Expanded Cosmetics Authority—and What It Means for Industry
Liquidated Damages for FDA‑Regulated Products
What They Are, How to Avoid Them, and How to Mitigate Successfully
FDA’s PFAS Cosmetics Report
Forever Chemicals, Federal Oversight, and the Changing Regulatory Landscape
FDA Launches Unified Adverse Event Monitoring System (AEMS), Expanding Safety Surveillance and Regulatory Oversight
On March 11, 2026, the U.S. Food and Drug Administration (FDA) announced the launch of the Adverse Event Monitoring System (AEMS), a centralized, AI-driven platform that modernizes the agency’s post-market safety surveillance framework across all regulated product categories. These include medical products, vaccines, medical devices, tobacco products, food, cosmetics, and veterinary medicines. AEMS represents a […]
Love, Labels, and Selling Self-Care Without Selling an Unapproved Drug
FDA’s Valentine’s Day Reminder for OTC Drug Claims
★★★★★
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.