Matt Brockmeier’s Post

Link to the public comments on FDA LDT rule-making: https://lnkd.in/dtKSv8-T It's still updating. In case you want to download them all and take a bird-eye view. 😆 https://lnkd.in/d3FdVpgx #regulation #clinicallaboratory #diagnostics #fda #fdaregulations

👋 US-FDA: Data Integrity for In Vivo Bioavailability and Bioequivalence Studies; Draft Guidance for Industry; Availability The US-FDA has published a new Guidance for Industry (ref. https://lnkd.in/eTzV-4Xs) 💪 Call to action: Whenever you have the chance to comment a predicate rule, regulation, directive, guidance or guideline document, please just do so. Agencies are writing these documents for all of us. To my knowledge, they are always happy to receive comments or additional ideas and proposals. I can hardly not understand people who complain about laws or guidelines, if they have not taken the chance to comment on these. 👍 What you get for your efforts of commenting? 1. Your comments or concerns are seriously read. Agencies listen to us. 2. You act in a best democratic manner - it just feels good and being part of it 3. You get an automated email - like here: 📩 Your comment was submitted successfully! Comment Tracking Number: xxxxxxxxxx Your comment has been sent for review. This process is dependent on agency public submission policies/procedures and processing times. Once the agency has posted your comment, you may view it on Regulations.gov using your Comment Tracking Number. Agency: FOOD AND DRUG ADMINISTRATION (FDA) Document Type: Other Title: Data Integrity for In Vivo Bioavailability and Bioequivalence Studies; Guidance for Industry; Draft Guidance Document ID: FDA-2024-D-1245-0002 💯 Just do it. Take some time (better invested as for your X-Box, PS, Switch etc.) and have fun.

Marijuana Rescheduling Comment Period Opens On May 21, 2024, the US Department of Justice's Notice of Proposed Rulemaking (NPRM) to reschedule marijuana from Schedule I to Schedule III opened to receive comments. Here's a link to provide public comments: https://lnkd.in/g-miSPeM Comments are due on or before July 22, 2024 and must be submitted electronically or postmarked by that date. Hearing requests may be electronically transmitted or sent in by mail on or before June 20, 2024. Remember that your comments are publicly available on the regulations.gov website although you may request redaction of proprietary information. You can also go online to view other comments as they become available. Click on the blue "Comment" button to post. You can attach a file (such as a formal letter) in addition to providing text in a comment field. Comments are intended to assist the rulemaking agency as it considers the structure or viability of new regulations/requirements. They are not used to determine popularity as an opinion poll based on the number of comments received or views expressed.

One week ago, the comment period for the Rescheduling of Marijuana closed. 🔒 During the comment period, around 43,000 comments were received. Now that the comment period is closed, the next phase of the process begins, evaluating all the comments. If intrigued, read some of the comments for yourself. 👇 It will be very interesting to see what happens next! https://lnkd.in/gT9rHJ5B

Another important highlight on DSCSA Guidance! Thanks Tish/Kala!

Blink and you miss it. FDA posted a revised #DSCSA EDDS guidance last week. It wasn't in the Federal Register and isn't on the FDA website. Kala Shankle spotted it at regulations dot gov https://lnkd.in/ep973UCi Some of the changes are cosmetic, like adding links to footnote 17. There are changes in section III.B. on homogenous and nonhomogenous cases and aggregation and inference. Section V on Enhanced Tracing has a couple of changes, including changing the first words in sections V.B. and C. from "Under section 582 of the FD&C Act" to "Beginning November 27 2023." Addressing everyone's favorite heartburn, handling errors and discrepancies, section V.D., there are some subtle changes to V.D.2. , Steps for Resolving Aggregation Errors and Other Discrepancies. Take a look!

DOJ Marijuana Rescheduling Notice of Proposed Rulemaking A quick status as of 6/26/2024. With 26 days remaining in the original 60-day comment period, regulations.gov has received more than 25,000 comments to the proposal to reschedule marijuana from schedule I to schedule III. Several comments requesting an extension to the 60-day period have been received so it’s quite likely we’ll see an additional 30-days or more added to the comment period. In addition, several groups have requested a hearing on the matter which will likely extend any outcome. June 20th was the deadline to request a hearing. The decision whether to hold a hearing is made by the DEA administrator. Should DEA grant a hearing, a notice will be posted in the Federal Register establishing the date and time. An agency administrative law judge would preside over the proceedings. Here’s the webpage if you want to reference the issue directly: https://lnkd.in/g-miSPeM

Pleased to see Derek Yach’s letter “World Health Organization should embrace tobacco harm reduction to save lives” published in The Lancet today: “Tobacco harm reduction is integral to the FCTC definition of tobacco control, but it instead emphasises bans, prohibitions, and regulations that undermine access for millions of people to safer alternative products, such as electronic nicotine delivery devices and nicotine pouches”, writes Derek Yach in his letter and concludes: “Under careful regulation, the power of industry could ensure that adult smokers have access to safer products as a route to quitting tobacco. Yes, tobacco companies who transform and offer safer alternatives will profit but that profit comes with potentially 100 million fewer premature deaths between 2025 and 2060.” It’s important that #policymakers, #PublicHealth bodies and #regulators take note of the progress that has been made in countries that have successfully implemented #TobaccoHarmReduction strategies. Read the full article here:

🔊 The comment period is officially open! 🔊 The DOJ's Notice of Proposed Rulemaking (NPRM) to reschedule marijuana from Schedule I to Schedule III is now open to public and industry comments. Here's a link to provide public comments: https://lnkd.in/g-miSPeM Voice your opinion, for or against the rescheduling. Comments are due by July 22, 2024. Comments are intended to assist the rulemaking agency regarding the structure or viability of new regulations/requirements moving forward.