Tag: FDA News
Prepping for a MoCRA and FDA Cosmetics Inspection In a recent News & Insights publication, we addressed FDA’s significant inspection increase, including top citations for each product category, and what to expect and how to prepare for an FDA routine surveillance inspection. With the implementation of the Modernization of Cosmetics Regulations Act of 2022 (MoCRA) […]
FDA recently announced its latest efforts to strengthen and modernize the 510(k) process and to advance the safety and effectiveness of medical devices. As part of its ongoing commitment to optimize the clarity, predictability and consistency of the 510(k) Program, the Agency announced the release of three new draft guidance documents in alignment with the […]
What to Expect and How to Prepare FDA’s renewed focus on foreign and domestic inspections via onsite routine surveillance inspections, unannounced inspections and remote regulatory assessments continues to climb across all FDA-regulated industries. Following a pandemic pause, foreign inspections are particularly on the rise with an estimated 1,636 facilities already investigated this year following a […]
FDA Announces Regulatory Partnership Arrangement with Ecuador Since 94% of the seafood consumed by volume in the U.S. is imported, the FDA has always been committed to ensuring that imported seafood meets the same food safety requirements as domestically produced foods. While the Agency has select equivalency agreements in place, the FDA announced the first […]
FDA Announces New Medical Device User Fees for FY 2024 FDA announced its update on medical device user fees for FY 2024, which runs October 1, 2023 through September 30, 2024. The updated user fees affect everything from FDA medical device establishment registration to marketing submissions, and applies to all medical devices: beauty and cosmetic […]
What You Need to Have in Place Now for MoCRA Cosmetic Product Substantiation While FDA cosmetic product safety has always been required, MoCRA ups the ante and ensures that companies can no longer hide behind cover-up. As we discussed in our June 26 News and Insights issue, “Prep + Prime for MoCRA”, MoCRA’s new safety […]
Today, FDA issued long-awaited draft guidance on cosmetic facility registrations and product listings, as required under the Modernization of Cosmetics Act Regulation of 2022 (MoCRA). The draft guidance, when finalized, will assist cosmetic companies with cosmetic product facility registration and product listing submissions including ingredients, to FDA. Cosmetic facility registration and product listing will be […]
In the story of “Ali Baba and the Forty Thieves” from The Arabian Nights, the phrase “Open Sesame” magically opens the mouth of a cave in which the Forty Thieves have hidden their plundered treasure. And now FDA is opening up discussion with industry regarding sesame regulations as the ninth major food allergen after observing practices involving […]
FDA and USDA Regulatory Updates on Lab Grown Meat Summer is synonymous with time at the beach, popsicles and grilling. But soon enough, you may be picking up cell-grown meat on your next grocery run. The U.S. Department of Agriculture (USDA) recently approved two companies, Good Meat and Upside Food, to sell lab-grown and cell-cultivated […]
Update to FDA’s 2023 Priorities for Foods FDA Releases Update of Priority Guidance Topics for the FDA Foods Program In efforts to provide continued transparency for stakeholders regarding foods program priorities, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response (OFPR) released an updated list of draft […]
★★★★★
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.
