Mini Suri’s Post

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DEA Orange Book - July 2024 Version A good reference book to keep on your desktop, DEA last updated its “Orange Book” in July 2024. The document is a list of DEA regulated controlled substances and listed chemicals that includes recent scheduling actions. The contents are constantly changing so it’s a good idea to periodically check for the latest version. A pdf copy is attached to this post. The document is divided into three sections that list the names of the substances as described in the Code of Federal Regulations (CFR). The substances are arranged alphabetically, then by DEA drug code number, and finally by schedule. It also provides a chronological history of Federal Register and effective dates of control. The “Other Names” column provides examples of alternate names for certain compounds, and in some instances provides examples of positional isomers.

CLSI’s latest perspective on the FDA ruling regarding Laboratory Developed Tests (LDTs) underscores the growing need for laboratories to adapt to regulatory changes proactively. The report not only highlights the collective concerns of the lab community but also emphasizes the importance of leveraging available resources, such as the CLSI’s comprehensive LDT Toolkit. This toolkit can empower labs to navigate regulatory shifts with greater control and preparedness, ensuring they remain compliant while continuing to innovate in test development. It's a timely reminder of the critical role that robust guidance plays in safeguarding the quality and reliability of laboratory testing in an evolving landscape.

CLSI’s latest perspective on the FDA ruling regarding Laboratory Developed Tests (LDTs) underscores the growing need for laboratories to adapt to regulatory changes proactively. The report not only highlights the collective concerns of the lab community but also emphasizes the importance of leveraging available resources, such as the CLSI’s comprehensive LDT Toolkit. This toolkit can empower labs to navigate regulatory shifts with greater control and preparedness, ensuring they remain compliant while continuing to innovate in test development. It's a timely reminder of the critical role that robust guidance plays in safeguarding the quality and reliability of laboratory testing in an evolving landscape.

What do stakeholders in the diagnostics industry need to know about the #FDA's final rule on the regulation of laboratory-developed tests (LDTs)? Join our upcoming webinar to get up to speed on the potential impacts if the rule goes into effect, political response and other critical implications. #LDTs Speakers: Paul Gadiock, Paul Hughes, James Ravitz, Mike Ryan and Rachel Stauffer

At the end of June, the European Commission launched its public consultation on the evaluation of the EU Regulation 2019/515 on the Mutual Recognition of Goods. The Mutual Recognition principle is of particular importance for the #biostimulant industry, as #fertilising products are not yet fully harmonised within the EU. EBIC has been following this process closely and is working closely with our members to prepare a submission on their behalf. If any EBIC member is having issues getting Mutual Recognition for their products lawfully sold in other EU Member States, now is the time to contact the EBIC Secretariat to make sure your experiences are part of our submission. Members are also invited to submit an individual response to the public consultation, which ends on September 26th: https://lnkd.in/em2PtzrQ Members are also invited to take part in a second, more targeted consultation for businesses with experience with the Mutual Recognition Procedure. This consultation ends on September 21st and can be found here: https://lnkd.in/eR22tW5W

#EU_REACH - Join our webinar on 6 June 2024 to find out what you need to know about the second call for evidence on the REACH restriction proposal on chromium (VI). Given the widened scope of the proposal, we will explain what information, in particular on uses of chromium (VI) substances added in the updated mandate, we are looking for. If you have questions, you can send them to our expert panel already in advance. #ChemicalSafetyEU

What do stakeholders in the diagnostics industry need to know about the #FDA's final rule on the regulation of laboratory-developed tests (LDTs)? Join our upcoming webinar to get up to speed on the potential impacts if the rule goes into effect, political response and other critical implications.

What do stakeholders in the diagnostics industry need to know about the #FDA's final rule on the regulation of laboratory-developed tests (LDTs)? Join our upcoming webinar to get up to speed on the potential impacts if the rule goes into effect, political response and other critical implications.

#EUHaveYourSay - We are looking for information for a potential #EU_REACH restriction on certain hexavalent #chromium substances. The call for evidence is composed of two surveys to gather information related to: ➡️exposure and compliance with limit values ➡️alternatives to Cr(VI) substances. Share your expertise and send your comments until 15 August 2024. #ChemicalSafetyEU