Enforcement Delayed by 6 Months
Update on FDA Cosmetic Product Facility Registration and Cosmetic Product Listing Requirements
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Tag: FDA News
Tis the Season for Cosmetic Registration and Product Listing (with a Slight Delay)
Last week, FDA provided a glossy update on ongoing activities related to the new cosmetic product facility registration and cosmetic product listing requirements that are now mandated under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). In our prior News & Insights articles here and here, we discussed cosmetic facility registration requirements, which includes […]
FDA Issues Eyedrops Products Warning
FDA Issues Warning to Avoid Purchase or Use of 26 Eyedrops Products from Several Major Brands due to Risk of Eye Infection
Celebrating Halloween With a Goulish Glow?
A Look at FDA’s Spooktacular Regulation of Decorative Contact Lenses and Makeup
It’s that Special Time of Year Again! FDA Device Registration Renewal
FDA’s 2023 device registration renewal period!
FDA Releases Updated Draft Guidance
On the Preventive Controls for Human Food Rule, Food Allergen Program and Acidified Foods
Avoid Blushing and Don’t Let GMP Violations Add to Your Highlight
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) […]
Moving the Needle and Modernizing the 510(k) Process
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the clarity, predictability and consistency of the 510(k) Program, the Agency announced the release of three new draft guidance documents in alignment with the […]
FDA Inspections on the Rise
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 […]
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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.