Drug approvals are often complex and time-consuming, even for generic versions of approved medications. Some of this complexity is unavoidable for good reasons, especially when it comes to patient safety. Much of the process is specifically designed to minimize the chance that new drugs – or new versions of existing ones – will cause harm.[…]
2 Key Factors to Accelerate Drug Approvals: Expertise and Relationships
blog, Bulk Active Ingredient, Regulatory, Supply Chain Tags: ANDACOVID19drug shortageFDAPAS Dec 29, 2020
The Fight Against the Opioid Epidemic
Opioid Antagonist Tags: 505b2ANDAGenericsGMP APIsOpioid AntagonistOpioid Epidemic Jan 16, 2020
The statistics are sobering. In the space of just one generation, the entire face of the United States changed. Over an 18-year span, more than 700,000 people died as the result of a drug overdose, according to data cited by the Centers for Disease Control and Prevention (CDCP). In 2017, nearly 70 percent of the[…]
Understanding 505(b)(2) Drug Development & API Supply Issues
LGM Pharma Tags: 505b1505b2505jANDANDA Nov 04, 2019
Situated between the NDA and the ANDA is an increasingly popular drug commercialization pathway – the 505(b)(2) – and it potentially offers pharmaceutical companies clear advantages. We’ve been working with clients for years on 505(b)(2) drugs. At present, we are working on well over 100 API projects using the 505(b)(2) pathway. But why is there[…]
