Stelios Tsinontides

Director, Office of Manufacturing Assessment in OPQ, CDER,
FDA. Views and information presented here are mine. Passionate
about Engineering Quality.

[Merck @Merck]

An antibody-drug conjugate (ADC) is a complex molecule designed to target and destroy cancer cells through the transport & delivery of chemotherapy.

[Stelios Tsinontides @STsinontides]

@Christodulides @kmitsotakis We stand stronger together!

[Scott Gottlieb, MD 🇺🇸 @ScottGottliebMD]

12 former commissioners of the FDA came together to write a Perspectives piece for the New England Journal of Medicine; raising our concerns about recent changes to vaccine approval policy at the FDA and its implications for patients and public health.

[Biosimilars Council @BiosimsCouncil]

The Biosimilars Council applauds the @US_FDA for draft guidance regarding switching studies intended to support a demonstration that a biological product is interchangeable with a reference product. #Biosimilars – with and without an interchangeability designation – are safe and effective, and lower price options for patients. Today's #FDA action is consistent with the Council’s recommendations and will maintain the FDA’s high standards of safety while speeding up patient access to essential medicines.

[Michael Davis, MD, PhD @FDACDERDirector]

The FDA is committed to the continued development and approval of high-quality, safe, and effective biosimilars and the increased access they can bring for patients.

[U.S. FDA @US_FDA]

"Our FY25 budget requests $12.3 million for supply chain work across nearly all product areas as well as establishing positions to coordinate these activities across the agency." -- @DrCaliff_FDA

[U.S. FDA @US_FDA]

Today, FDA Commissioner @DrCaliff_FDA testified before the House Oversight Committee on the agency's work to protect and promote the public health.

[U.S. FDA @US_FDA]

"Preventing and mitigating supply chain issues in the industries we regulate has been a primary focus" of the FDA. -- @DrCaliff_FDA

[Michael Davis, MD, PhD @FDACDERDirector]

The required updates will address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants to ensure the prescribing information is made consistent across the entire class of these medicines.

[FDA Tracker @FDA_Track]

Time to Enforce President Biden’s Scientific Integrity Memorandum | RealClearHealth https://t.co/z3dwAe9QDF

[Greek News USA @GreekNewsUSA]

#GreekAmerican organizations (@MikeManatos @OrderOfAHEPA @TheAHIinDC @HellenicLeaders @cyprususchamber)
united during the 38th @PSEKA #Cyprus Conference and presented a strong front in Capitol Hill for supporting the struggle of the Cypriot people for freedom and justice.

[Greek News USA @GreekNewsUSA]

Ο Κύπριος κυβερνητικός εκπρόσωπος @letymbiotis βρέθηκε για πρώτη φορά κοντά στην #ομογένεια εκπροσωπώντας τη κυβέρνηση στο 38ο Συνέδριο της ΠΣΕΚΑ που πραγματοποιείται στην Ουάσινγκτον. #Κύπρος #ΗΠΑ #Ελλάδα

[Petros Kasfikis @PetrosKas]

Congressman @ChrisPappasNH accepted @PSEKA Award, highlighting the strong bipartisan support that the Cypriot cause is enjoying in the U.S. Congress.

[Stelios Tsinontides @STsinontides]

With advanced manufacturing technologies we engineer #Quality into the process and product. Everyone wins - Manufacturers, Regulators and Patients! https://t.co/ZJXuG4CpMA

[Stelios Tsinontides @STsinontides]

https://t.co/DbaFhzaA2m

[BPTF @BPTF]

The Manufacturing Edge on Path to Market https://t.co/lNWZPDctzZ via @pharmexec

[Stelios Tsinontides @STsinontides]

We continue to look for talented individuals with experience in microbiology, sterile manufacturing, biologics manufacturing, pharmaceutical manufacturing, and/or CGMP experience to join our team. Use posting below to apply before July 7. https://t.co/bu9N1g0O4L

[Michael Davis, MD, PhD @FDACDERDirector]

“We can't afford to delay guidance or actions that bring us closer to the treatments patients need to live longer, healthier lives. By creating this video for all stakeholders, we hope to provide that sense of urgency, meaning and value in patient-focused drug development.”

[Stelios Tsinontides @STsinontides]

We continue to hire talented individuals with experience in microbiology, sterile manufacturing, biologics manufacturing, pharmaceutical manufacturing, and/or CGMP experience. Use posting below to apply. https://t.co/EP6vOLbiG5

[Stelios Tsinontides @STsinontides]

https://t.co/6Mw2XABBxX