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CDER laid out how it will review newly identified safety signals (NISS) for marketed drugs, in a new Manual of Policies and Procedures (MAPP). Read More
The European Medicines Agency has introduced a new system for reporting drug shortages and potential supply chain disruptions as the COVID-19 pandemic takes a toll on the stock of some critical medicines. Read More
The European Medicines Agency (EMA) recommended that good manufacturing practice (GMP) certificates for drugmakers be extended until the end of 2021 to avoid potential drug supply-chain disruptions during the pandemic. Read More
A Federal appeals court has upheld the FDA’s denial of a new drug application for an abuse-deterrent formulation of oxycodone from Pharmaceutical Manufacturing Research Services (PMRS). Read More
The agency noted the positive results from a National Institutes of Health clinical trial of the antiviral drug, but said it is too early to draw any conclusions. Read More
To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance yesterday exempting certain COVID-19 products from tracing and identification requirements. Read More
Pharmacy benefit manager (PBM) reimbursements to pharmacies have failed to keep up with price increases for generic drugs, according to an analysis by 3 Axis Advisors, a consulting group that tracks drug supply-chain inefficiencies and pricing. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is relaxing some GMP requirements to help manufacturers overcome challenges during the COVID-19 pandemic. Read More
In an emergency final guidance released yesterday, the FDA agency said it is temporarily relaxing its regulations for repackaging and combining units of propofol during the COVID-19 pandemic. Read More