The USFDA has established an office in India to oversee the number of Indian manufacturers qualified to supply generic ...

DCGI has sought post-market surveillance data from the drugmakers of two fixed-dose combination medicines—Imipramine Hydrochloride IP + Diazepam IP tablets used to ease co-morbid anxiety, and ...

IPA also stated that while generics are priced lower than the corresponding brands, it is unfair and unacceptable to link quality with cost.

The Central Drugs Standard Control Organisation (CDSCO) has renamed its post licensure monitoring division as Post Marketing Drugs Safety Monitoring Division (PMDSMD), with immediate effect. The ...

Pharmaceutical major Sun Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central ...

The FDA provided guidance on the design of the APOLLO post-marketing confirmatory trial, which will support an accelerated approval filing for bitopertin. Disc plans to submit a New Drug ...