FDA’s Post

Securing the pharmaceutical supply chain is essential to protecting the health and safety of patients in countries around the world; at each stage of the #supplychain The APEC - Asia-Pacific Economic Cooperation Supply Chain Security Toolkit provides a blueprint and resources to ensure a safe, secure, and resilient supply chain; that can ultimately ensure quality and the health and safety of patients globally. The toolkit can be found on the US Pharmacopeia website.

It’s really helpful to understand the whole picture of product release and supply security using modern tools to confirm the product manufacutured and distributed is compliance with GMP, GDP and APEC local regulations.

#RegUpdatesWithRegDesk To enhance the oversight of medical device operations, standardize practices, and ensure the safety of devices for public use, the State Food and Drug Administration has updated the "𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐎𝐩𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐬."  These revisions, effective from July 1, 2024, replace the previous announcement (2014 No. 58) on the implementation of quality management standards. The aim is to align with laws and regulations, promoting industry standards and the overall safety and effectiveness of medical devices. Link: 👉 https://lnkd.in/gv7u3MzX Follow: 👉 RegDesk and get daily regulatory alerts sent straight to your inbox. Get Started: 👉 https://lnkd.in/d8yWnPkj #MedicalDeviceSafety #QualityManagement #IndustryCompliance #NMPA #China

IQVIA's 26th Controlled Substance and State Regulatory Conference Registration for our annual conference has opened! Please join us in Louisville, KY for industry's premiere event delivering insights for regulatory excellence. Here's a link to register: https://lnkd.in/gqGf7-f6 Conference dates are September 18-20 at the Galt House Hotel. Here's a quick look at the current agenda which incluldes general sessions, breakout groups, and interactive roundtables. Topics are subject to change. * Update by DEA Headquarters on regulations and compliance efforts * Tomorrow’s Regulations Today – What’s Ahead for SOM * Insights and Takeaways from the Current Enforcement Environment * State Regulatory Updates - Registration, Reporting and Other Controlled Substance Considerations * Drug Supply Chain Security Act: Ready or not! New to Controlled Substance Compliance? Join our DEA 101 breakout session to build foundational knowledge and gain insights addressing regulatory pitfalls and industry challenges.

IQVIA's 26th Controlled Substance and State Regulatory Conference Registration for our annual conference has opened! Please join us in Louisville, KY for industry's premiere event delivering insights for regulatory excellence. Here's a link to register: https://lnkd.in/gqGf7-f6 Conference dates are September 18-20 at the Galt House Hotel. Here's a quick look at the current agenda which incluldes general sessions, breakout groups, and interactive roundtables. Topics are subject to change. * Update by DEA Headquarters on regulations and compliance efforts (confirmed) * Tomorrow’s Regulations Today – What’s Ahead for SOM * Navigating the New Quota Requirements * Insights and Takeaways from the Current Enforcement Environment * State Regulatory Updates - Registration, Reporting and Other Controlled Substance Considerations * Drug Supply Chain Security Act: Ready or not! New to Controlled Substance Compliance? Join our DEA 101 breakout session to build foundational knowledge and gain insights addressing regulatory pitfalls and industry challenges.

IQVIA's 26th Controlled Substance and State Regulatory Conference Registration for our annual conference has opened! Please join us in Louisville, KY for industry's premiere event delivering insights for regulatory excellence. Here's a link to register: https://lnkd.in/gqGf7-f6 Conference dates are September 18-20 at the Galt House Hotel. Here's a quick look at the current agenda which incluldes general sessions, breakout groups, and interactive roundtables. Topics are subject to change. * Update by DEA Headquarters on regulations and compliance efforts (confirmed) * Tomorrow’s Regulations Today – What’s Ahead for SOM * Navigating the New Quota Requirements * Insights and Takeaways from the Current Enforcement Environment * State Regulatory Updates - Registration, Reporting and Other Controlled Substance Considerations * Drug Supply Chain Security Act: Ready or not! New to Controlled Substance Compliance? Join our DEA 101 breakout session to build foundational knowledge and gain insights addressing regulatory pitfalls and industry challenges.

Dive into our latest article series with MasterControl to uncover the secrets of successful expansion into the U.S. market. Part 1 highlighted regulatory disparities; now, Part 2 unveils how to leverage audits for FDA compliance and streamlined entry. More: https://hubs.la/Q02qbTT00 #MedTech #FDACompliance #MarketExpansion

💡 Quick Fact The CPNP makes the information available electronically to competent authorities (for the purposes of market surveillance, market analysis, evaluation and consumer information) and poison centers or similar bodies established by EU countries (for the purposes of medical treatment). Learn more about cosmetic product notification in the EU in our new blog post: https://lnkd.in/gMgPbfiU #cosmeticsregulation #regulatorycompliance #cosmetiscsafety

Navigating the EU and UK cosmetic markets? 🇪🇺🇬🇧 Discover the 5 essential steps for product placement, PIF creation, and regulatory compliance. Our experts simplify the journey, offering guidance, PIF creation, Safety Data Sheets, and clinical testing support. For peace of mind and successful market entry, connect with our compliance team today. Let ADSL's expertise guide you. Learn more now! https://lnkd.in/euC_7_Hh #CosmeticRegulations #EUUKCosmetics #ComplianceExperts

https://lnkd.in/eXyXiwzd As you an clearly see tobacco related compliance actions skew the numbers of compliance actions to no end. This of low impact non inspection and are the boiler plate direct issuance Letters. No inspections just remote desk work. At the same time tobacco violations and general defiance of FDA regulations on tabacco related outfits like the vape outfits is at an all time high. One can say FDA has lost the vape war. At the same time FDA pads and uses the tabacco numbers to show Congress we are on top of compliance actions. Now if we look at real FDA work on drugs, devices and food, we see incredible low numbers for the years 2009-2024 accounted for. I suppose this is one way of looking at the numbers. Too bad the dashboard does not account for the number of consumers exposure to risk as confirmed by investigation. Including the ultimate risk. You know accountability of non effective recalls and other stats that reflect real life evidence as the Bow Tie likes to mention. Interesting enough the numbers are so low. How low are they? So low in fact the you can’t even do foot massaging. That said it continues to look like the dashboard of a Pinto, remember those.