Tag: FDA News
New Fiscal Year 2024 Rates and What You Need to Know
Last week, FDA announced the rates for over-the-counter (OTC) monograph drug facility fees for fiscal year (FY) 2024 with a noticeable 31% marked rate increase from FY 2023 rates: FY 2024 rates include $34,166 for a Monograph Drug Facility (MDF), and $22,777 for a Contract Manufacturing Organization (CMO). As a reminder, OTC monograph drug facility […]
Implications for Food Industry and Businesses
FDA’s recent step in issuing Import Alert 99-48 for food products containing chemical contaminants has sent ripples through the food industry and businesses engaged in food production. Particularly affected are companies involved in the production of products containing per- and polyfluoroalkyl substances (PFAS) or other chemical contaminants . PFAS are a group of man-made chemicals […]
FDA Updates Draft Guidance for Medical Device Submissions: The Q-Submission Program
In the intricate landscape of medical device development and approval, navigating regulatory pathways can be daunting. Among the pivotal steps in this journey lies the FDA Pre-Submission process. This process serves as a crucial bridge between medical device developers and regulatory authority, facilitating effective communication, feedback, and ultimately, smoother pathways towards product clearance or approval. […]
FDA Issues Final Guidance on Updated Procedures and Timeframes
This week, the FDA announced the availability of final guidance for the dietary supplement industry regarding procedures and timeframes for premarket safety notifications, commonly referred to as new dietary ingredient notifications (NDINs). Aimed at improving the rate of compliance with the new dietary ingredient (NDI) notification requirement, the quality of NDI notifications, and ensuring the […]
FDA Proposes Modifications to Medical Device User Fee Small Business Qualification and Certification
Last week, FDA issued draft guidance regarding updates for its Medical Device User Fee Small Business Qualification and Certification program, potentially opening a (small) window for FDA waiver of the medical device establishment registration fee for device establishments that are small businesses and that qualify for financial hardship. U.S. FDA medical device establishment registration and […]
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 […]
FDA Makes Changes to Device GMPs to Align More Closely with International Consensus Standards.
On January 31, 2024, FDA issued a final rule, which will amend medical device current good manufacturing practice (cGMP) requirements of the Quality System (QS) Regulation under 21 CFR Part 820, to more closely align with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the […]
FDA Showcases New Regulation Portal for Food + Cosmetics Program
In efforts to increase transparency and support stakeholders with understanding the FDA’s regulatory agenda, the Agency unveiled its new website identifying regulations that the Agency plans to publish by October 2024, and longer-term regulations the FDA is prioritizing for publication at a later date. Aimed at informing industry on “what’s ahead”, the FDA Foods Program […]
What Should I Really Be Doing Now to Tone and Brighten for FDA Cosmetics Compliance?
While it may still seem off in the distance, cosmetic companies are required to comply with the new registration and listing requirements of the Modernization of Cosmetic Regulations Act (MoCRA) by July 1, 2024, and several other compliance requirements which are currently in effect. This includes labeling and substantiation compliance and recordkeeping, having an adverse […]
Quickly Remove Potentially Violative Product and Minimize Business Disruption and Loss
A pantry staple, granola bars and granola cereals faced a nationwide product recall just before the holidays by the Quaker Oats Company due to potential contamination with Salmonella, a high-risk bacteria that can cause fatal infections in vulnerable populations such as children, the elderly, and those with weakened immune systems. The recall affected Quaker Chewy […]
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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.
