Newsletter - February 4, 2021
FDA’s Between a Rock and a Hard Place for its GMP Inspections
It is no secret that FDA stopped all GMP inspections in March of last year due to the pandemic and then resumed highly curtailed risk-based prioritized domestic audits in the Fall. All through FDA used alternate ways to verify GMP compliance for US and foreign manufacturers. But the GAO does not believe it is acceptable and should continue...Read More
Stop Asking the FDA for Covid Vaccine Supply
Apparently, FDA has been getting calls from consumers asking about where to get the Covid vaccines leading it to release the public announcement that it does not control distribution of vaccines, only their approval. It is obvious to the regulated industry, but the public has a different perception of the FDA...Read More
FDA’s Between a Rock and a Hard Place for its GMP Inspections
It is no secret that FDA stopped all GMP inspections in March of last year due to the pandemic and then resumed highly curtailed risk-based prioritized domestic audits in the Fall. All through FDA used alternate ways to verify GMP compliance for US and foreign manufacturers. But the GAO does not believe it is acceptable and should continue...Read More
Stop Asking the FDA for Covid Vaccine Supply
Apparently, FDA has been getting calls from consumers asking about where to get the Covid vaccines leading it to release the public announcement that it does not control distribution of vaccines, only their approval. It is obvious to the regulated industry, but the public has a different perception of the FDA...Read More
