READ: Mastering Drug Product Remediation: 5 Essential Principles Post FDA Action
https://t.co/DnOQBUNvPt
"...navigating the intricate landscape of facility and Quality Management System (QMS) remediation following FDA enforcement actions demands precision, foresight, and a commitment to sustainable change." Click to Read More!
#FDA #Compliance #Remediation #Inspections #Manufacturing #Generics #Biologics #MedicalDevices
I enjoyed spending time at FDLI this year once again. In today’s fireside chat, I talked about FDA’s priorities, the amazing advance of technology that requires us to continue to evolve at FDA and our many efforts to help improve public health.
We’ll see you at the #FDLI2024 Annual Conference. This 75th Anniversary celebration is scheduled for May 15-16 in Washington, DC. To set up an in-person meeting with our team at the conference, learn more about our #ExpertWitnessServices, & register for the event: https://t.co/AFAkw4iHCx
@foodanddruglaw
#foodanddrug #pharmaceuticals #drugmanufacturing #pharmaconsulting
READ: AI Laws on the Move
https://t.co/EiL0daPrGh
Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace?
#AI #ArtificialIntelligence #RegulatoryAffairs #FDA #Compliance #Generics #MedicalDevices #MedTech #BioTech
What's Wrong With This Picture? "There needs to be a fix to this irrational [generic drug] pricing model." - Bob Pollock from Lachman Consultants @LachmanConsult
https://t.co/KmPCjzDycx
We’re looking forward to seeing you at the #AAM#Access2024 annual meeting, JW Marriott, Tampa, Florida on February 5-7. You’re invited to visit with us at booth 11 & meet the #LachmanTeam. Book a meeting & Experience. Excellence.™ at the #AAMconference: https://t.co/jrC6xX0Wpv
Join #Access2024 to connect with industry leaders and chart the future of #generics and #biosimilars. Attend professional networking opportunities and social events to advance your career.
📍February 5–7, 2023 | Tampa, FL
➡️ Register: https://t.co/g1Z3G8TXQF #ThrowbackThursday
BLOG: Happy Thanksgiving Y’all!
https://t.co/MRLFkuVKgt
"I was trying to come up with something clever to say to put a smile on your faces, but I find it hard this year. So, I chose to develop a Thanksgiving library list to share with you that will hopefully bring a smile to your face." Click to Read More!
#thanksgiving #holidays #SilenceoftheYams
Frances M. Zipp – Recipient of the Joseph X. Phillips Professional Achievement Award
https://t.co/WyRbzpA9op
Please join us in congratulating Fran for this prestigious award recognizing all that she continues to do for our industry!
#ISPE@ISPEorg
See you in DC! With more than 40 FDA experts participating as speakers and panelists, #PDAFDA is the place to be 18-20 Sept. for the latest on important issues related to CGMP and quality assurance. Livestream option also available! https://t.co/4yQsyfVw0B
BLOG: 5 Reasons Why You Should Perform a Mock Inspection Now
https://t.co/XC8Pu9vgPw
"Whether you’re overseas or right here at home in the U.S., FDA regulatory oversight is rigorous, particularly after COVID19 now that the FDA has aggressively resumed on-the-ground inspections..." Click to Read More
#Generics #Biologics #MedicalDevices #FDA #Inspections
LATEST NEWS: NDSRIs – Alignment At Last (Sort Of)
"The industry as a whole rejoiced on Friday with the publication of the new NDSRI guidance from the FDA, previously discussed here. Now that we all have had more time to carefully read and absorb the details posted by the FDA in the guidance and on the corresponding webpage, many will discover that there are still a few discrepancies from other health authorities as well as a new call to action for manufacturers and application holders in the U.S." READ MORE...
https://t.co/kUbe0O8KhR
#NDSRI #Nitrosamines #Compliance #FDA #ANDA #OTC #NDA