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The European Medicines Agency (EMA) has updated its advice on impurity testing for nitrosamines, expanding it to include some biological medicines. Read More
The FDA is easing its requirements for the amount of reserve samples that drug sponsors must retain for bioavailability and bioequivalence studies, citing improved testing methods. Read More
Drugmakers successfully completed a majority of postmarketing requirements and commitments in fiscal 2019, the FDA said in its latest annual report. Read More
A new bill introduced by Sen. Gary Peters (D-Mich.) would give the FDA the authority to recall unsafe drug products, a power it currently does not have. Read More
An FDA sampling study found that difficult-to-manufacture drug products sold in the U.S. consistently met quality standards even when they were made abroad. Read More
The FDA has released a question-and-answer guidance to clarify its policies on inspections, pending drug applications and changes in manufacturing facilities for approved drug products during the COVID-19 pandemic. Read More
Tecentriq is currently approved with a different form of paclitaxel, Abraxane (paclitaxel protein-bound), for adults with mTNBC whose tumors express the PD-L1 protein. Read More
In a Senate hearing yesterday, National Institutes of Health Director Francis Collins applauded AstraZeneca’s decision to halt its phase 3 COVID-19 vaccine trial due to an unexplained illness — and said the incident should reassure the public that companies are not compromising when it comes to the safety of their vaccine candidates. Read More
Three House Democrat committee chairs are demanding that HHS Secretary Alex Azar detail how the department is gearing up for COVID-19 vaccine distribution, how it is working to increase public faith in a vaccine and how it will ensure its decisions aren’t influenced by politics. Read More
President Trump’s efforts to coax a new strategy from industry to lower drug prices by means of a brandished executive order have been met with silence so far, and the administration is running out of time to show some headway on drug pricing before the Nov. 3 presidential election. Read More
In addition to the risk of allergic contact dermatitis, the agency also found that there is inadequate evidence that the ingredient in the drug is effective. Read More
After returning from a month-long congressional hiatus, Senate Majority Leader Mitch McConnell (R-Ky) unveiled a proposed coronavirus relief package on Tuesday that includes $31 billion for COVID-19 medical countermeasures. Read More