Dispatches from AAPS
Peru's GMP requirements mean delayed approvals, says expert
Stricter GMP requirements in Peru are increasing the time it takes to get drugs approved and may not be giving regulators any useful additional information.
Dispatches from AAPS
Stricter GMP requirements in Peru are increasing the time it takes to get drugs approved and may not be giving regulators any useful additional information.
Sino-US CRO Pharmaron has signed a drug discovery partnership with Anglo-Swedish drug major AstraZeneca.
Dispatches from AAPS
Manufacturers trying to prove the similarity of their biosimilars must consider that regulations and reference medicines differ in different markets says Pfizer.
A new trade organisation intended to give clinical research sites a voice was launched at industry event earlier this week.
Dispatches from AAPS
Make information about generic production readily available when working with vendors in emerging markets for quicker US approval, says the FDA.
SternMaid has invested €14m in its Wittenburg factory to enlarge capacity and extend the range of its products and services, involving the introduction of new fluid bed technology.