L4SB
FEBRUARY 5, 2025
Navigating the legal landscape is a challenge for manufacturers, as their operations are subject to an array of complex and evolving regulations. Understanding these legal concerns and addressing them proactively.
FDA Law Blog
MARCH 7, 2024
Gibbs — Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical device submissions that require a user fee.
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FDA Law Blog
NOVEMBER 15, 2022
By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.
Customs & International Trade Law
MAY 24, 2023
Recent news on the Voluntary Cosmetic Regulations Program (VRCP) The VCRP was a voluntary program that allowed manufacturers, packers, and distributors of cosmetic products to submit product information to the FDA. Existing facilities have until December 29, 2023 to register.
Mondaq
NOVEMBER 17, 2021
Cybercrime is a global phenomenon that does not discriminate on the size of your organisation, whether you are in finance, manufacturing, national government, small business, or entrepreneur.
JURIST
FEBRUARY 14, 2022
The blockade created significant supply chain issues on both sides of the border leading to concerns from the White House, temporary manufacturing plant closures in Canada, and renewed calls from some US politicians for more domestic—or made in America—production.
FDA Law Blog
OCTOBER 30, 2023
Houck — The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. 73,044 (Oct. DEA’s notice of updates with the Special Surveillance List is attached here.
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