FDA grants to boost manufacturing, regulatory science

The FDA has made a potential $35 million commitment that aims to improve both drug-making and regulation. The goal of the FDA grants to the National Institute for Pharmaceutical Technology and Education (NIPTE) is to improve drug manufacturing standards.

"Investment in research of drug development and manufacturing will improve America's manufacturing competitiveness and create high-paying jobs at home," according to an NIPTE statement. It will also "help to reverse" offshoring and outsourcing trends by decreasing the cost of manufacture and by improving quality and safety of drugs.

"Progress in this area will mean safer, more efficient and less costly drug production here in the U.S.," says Helen Winkle, director for FDA's Office of Pharmaceutical Sciences, in the statement.

The nonprofit NIPTE says its goal is to "increase science and engineering-based understanding" of drug manufacturing so "novel" technologies can be developed and science-based regulations can be implemented.

- here's the statement

Suggested Articles

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.