Newsletter - October 31, 2019
Is FDA Ignoring Complaints About Generic Drug Quality?
For the last several years, questions have been raised in public about the quality of drugs imported into the US from India and China, mostly based on FDA audit findings and Warning Letters. At the same time FDA has repeatedly insisted that its system for review and inspections is adequate to protect the US drug supply chain...Read More
FDA’s Solutions to Counter Drug Shortage – Increased Drug Prices
A joint government task force lead by FDA to study the causes of drug shortages found that these shortages occur primarily because the manufacturers are unable to charge higher prices for their drugs even when there is a shortage and that it takes a longer than anticipated time to catch-up once a drug is in short supply...Read More
Is FDA Ignoring Complaints About Generic Drug Quality?
For the last several years, questions have been raised in public about the quality of drugs imported into the US from India and China, mostly based on FDA audit findings and Warning Letters. At the same time FDA has repeatedly insisted that its system for review and inspections is adequate to protect the US drug supply chain...Read More
FDA’s Solutions to Counter Drug Shortage – Increased Drug Prices
A joint government task force lead by FDA to study the causes of drug shortages found that these shortages occur primarily because the manufacturers are unable to charge higher prices for their drugs even when there is a shortage and that it takes a longer than anticipated time to catch-up once a drug is in short supply...Read More