Ten Count Consulting’s Post

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!

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

Calling All Comments – DEA's Controlled Substance Destruction Alternatives ANPRM A quick check of regulations.gov this afternoon (2/22/2024) for DEA’s Advance Notice of Proposed Rulemaking (ANPRM) regarding controlled substance destruction alternatives revealed a scant thirty comments posted. As you may recall, DEA is “seeking information about destruction processes which may be used to render controlled substances to a non-retrievable state.”  DEA extended the comment period to the ANPRM until on or before April 1, 2024. Ten questions compose the bulk of the notice and help shape the issue, DEA’s interest, and your response. This is a challenging concept that has been under consideration for a long time. I strongly encourage those in industry, particularly the research and development community, to share your experience and practices to assist DEA in this issue. Comments can be made electronically, and any proprietary information redacted. Here's a link to the ANPRM with its blue “Comment” button: https://lnkd.in/ezp9jfjj. Don't pass up this opportunity to help DEA shape new regulations.

I've submitted my comments to the FDA QMM Quality Management Maturity draft document. Commenting deadline is today. The goals of the QMM program are all important goals, which are an expectation to Quality leaders and other senior company management irrespective of the QMM program. Reducing the global drug shortage problem will require new ways of working together more so than adding more reporting requirements for companies. All five QMM practice areas are covered by ICHQ10 and ISO9001:2015. Several recommendations are provided including 1) Further develop and implement the international documents ICH Q10 and ISO9001:2015 to achieve QMM program goals 1, 3, and 4 instead of developing a new Program specific for the United States of America. 2) Providing newer and more detailed data (percentages and absolute values) for causes of drug shortages (existing is 6-10 years old), type of product in drug shortage (percentage generics vs branded) and perform a 5 Why root cause analysis (or alternative root cause analysis tool) of the drug shortages to better clarify the problem statement. The recommendations, rationale and background are found here: https://lnkd.in/gBtP4QDX

Your favorite anti-drug/ anti-science federal agency, Drug Endorcement Agency, has moved to place DOI and DOC, two research chemicals with no demonstrated history of risk of abuse and significant value to researchers, into Schedule I of the Controlled Substances Act. And they did so over the holidays, to avoid scrutiny from the industry that’s trying to bring psychedelic healing to the masses. They already tried to pull this in 2022 but withdrew their proposal in response to criticism from scientists and researchers and lawyers who are paying attention. Below is a link to comment on this proposed rule: https://lnkd.in/gT7qtcKG Let them know what you think. After all, even though they have forgotten, DEA works for you.

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.

🔍 𝐃𝐞𝐥𝐯𝐞 𝐢𝐧𝐭𝐨 𝐭𝐡𝐞 𝐄𝐬𝐬𝐞𝐧𝐭𝐢𝐚𝐥𝐬 𝐨𝐟 𝐏𝐌𝐂𝐅 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬 𝐮𝐧𝐝𝐞𝐫 𝐄𝐔 𝐌𝐃𝐑 Curious about navigating the intricacies of Post-Market Clinical Follow-Up under the EU Medical Device Regulation? Look no further! Our latest article is your roadmap to understanding #PMCF requirements, uncovering best practices, and establishing robust processes: https://lnkd.in/gs4ZUuxK Gain insights into: ▶ The significance of PMCF in ensuring ongoing device safety and performance  ▶ Key requirements outlined in the #EUMDR for PMCF implementation  ▶ Best practices for designing and executing effective PMCF studies  ▶ Strategies for data collection, analysis, and reporting to meet #regulatory standards Embark on the journey to #compliance excellence and elevate your PMCF practices today! 📧 Get in touch: https://lnkd.in/g9bGxh6U for all your EU #MDR related regulatory questions, concerns, and queries. #pmcfstudies #mdrcompliance #europeanunion #medicaldevices #pms #regulatoryaffairs #regulatorycompliance #regulatorysubmissions #cer #PostMarketSurveillance #clinicalevaluation #systematicreview #cep #eu #notifiedbodies 

🔊 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.

Last Opportunity To Comment on DEA’s Proposed 2024 Quota Notice Today, December 4, 2023, is the final day of the 30-day comment period for DEA’s Notice with Request for Comments regarding its proposed 2024 aggregate production quotas and assessment of annual needs for schedule I and II controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. As of 11:59 pm last night, more than 4,000 comments have been received to the docket. Approximately 3,600 have been posted. Here’s a link if you want to wade through the comments. https://lnkd.in/g9jeDaYm A quick word search of the posted comments indicates that 3,097 contain the word “pain” (approx. 86%) and 71 comments the word “ADHD” (approx. 2%). It’ll take DEA a while to sort through the comments and prepare its final notice regarding established quotas for calendar year 2024. Look for something prior to the first of the new year.