Politwoops

Globalization of drug manufacturing adds new complexities to the U.S. supply chain. API may be manufactured in one country, shipped to another country for final manufacturing that incorporates ingredients from a third country. The finished product is then imported to the U.S. https://t.co/NxhEL4B98A

To keep pace, FDA has established an efficient, nimble and modern framework to help assure that all drugs, no matter where manufactured, whether brand name, biosimilar or generic, prescription or OTC, meet the same high-quality standards.

FDA’s inspections program is a large-scale endeavor. We shared data on our risk-based FY17 inspections in a stmt issued in Sept. 2018: https://t.co/SaiOcLdXmH We also outlined our risk-based program in a #sundaytweetorial last year: https://t.co/WsOyNd9A1t QT @SGottliebFDA: Patients expect and deserve high-quality drugs. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about how FDA s… https://t.co/6fJaXOJtSi)

A las Fuerzas Armadas de VZ, este es el momento de recuperar su honor y dignidad, y ponerse de lado del pueblo Venezolano en esta noble causa de la libertad. Y al valiente pueblo VZ, no están solos. La admin del pres Trump, el Congreso de EEUU, si todo EEUU están c/ ud #Venezuela QT @MarioDB: https://t.co/Y3ASHn7pHm)

Post GDUFA #FDA made a concerted effort to inspect every generic facility allowing us to develop a very sophisticated risk-based model to target future inspections; making our inspectional work more focused, more efficient, and more effective.

And for anyone trying to parse a distinction between "surveillance" inspections of existing product lines, and inspections for new products launching for the first time, there's a key fact: new drugs and drugs on market are often made at same sites.....

So when FDA goes in and inspects a facility for a new product launch, it's also getting a good look at the whole facility, which can address issues associated with all the other product lines being produced in that same manufacturing site.

Pre-approval inspections and surveillance inspections, which are increasing in numbers NOT FALLING, work hand-in-hand as integrated elements of a comprehensive approach to ensuring quality and safety of generics.

RT @SGottliebFDA: And for anyone trying to parse a distinction between "surveillance" inspections of existing product lines, and insp… https://t.co/d19lteli8I

@annaedney Important Distinction: New launches and existing drugs are typically made in same plants. When we go in and inspect facility for a new launch we get a look at the entire facility and their systems, which can address systemic issues associated with other products made at the site.