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The FDA has an established office in India overseeing the number of qualified manufacturers supplying genericmedicines to the US. It has also introduced the Foreign Unannounced Inspection Pilot programme, conducting multiple unannounced and short-term notice inspections in India since March 2022.
Omnibus Spending Law: Provisions Will Bolster Medicines Supply Chain Insights and Advanced Manufacturing Technologies Investments to create a more resilient medicines supply chain and prepare for future public health emergencies are among key provisions of the mammoth $1.7
For example, while some stakeholders may perceive PCM to be primarily for innovators and not for makers of genericmedicines or biotech companies, it “can be for generic companies, biotechnology companies, and so on, and we have had engagements with generic drug companies in our emerging technologies program already,” Fisher said.
Coburn spotlighted four related objectives: Increasing manufacturing flexibility while maintaining quality and accountability; improving supply chain visibility; increasing redundancies in suppliers and decreasing supply chain length; and modernizing and optimizing stockpiling. While not specifically noted during the panel, the U.S.
in 2022 to 1% in 2023 due to the “tightening of monetary and financial conditions”. Koerber-Walker discussed how the Inflation Reduction Act, introduced in 2022 , may benefit biologics companies’ funding plans going into the next year. Certain companies will struggle more than others with accruing investment from venture capital firms.
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