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Despite the pandemic, the FDA’s product review performance as it related to the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Amendments (BsUFA) remained relatively stable through fiscal year 2020 to fiscal year 2021, according to the latest data posted on the agency’s “dashboard” — which tracks how well the agency is living up to its review commitments under the user fee programs. Read More
The next FDA commissioner — most likely Robert Califf, who is now awaiting a confirmation vote by the Senate — will face a tough 2022 on multiple fronts, beyond just dealing with the ongoing pandemic and drug supply-chain shortages. Read More
The European Parliament has endorsed a plan to strengthen the powers of the European Medicines Agency (EMA) to increase monitoring of the supply chain for drugs and medical devices. Read More
In early January, HHS appealed decisions issued in three federal courts that called into question the agency’s authority to punish drug companies who refuse to participate in the 340B program. Read More
Gilead Sciences has announced that it’s removing counterfeit versions of its HIV medications Biktarvy and Descovy from the U.S. supply chain following the discovery that thousands of bottles of the counterfeit meds were being distributed across nine states. Read More
Teva Pharmaceuticals has agreed to pay $420 million to settle shareholder litigation alleging the company concealed an anti-competitive scheme to fix the prices of about 50 generic drugs, according to court documents filed in the U.S. District Court for the District of Connecticut on Tuesday. Read More
In responses to two Republican senators, Robert Califf — the Biden administration’s nominee for FDA commissioner — provided a deeper look into the priorities he would set at the helm of the agency if confirmed to the top post once again. Read More