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The FDA released a straight-to-final guidance yesterday on steps drugmakers should take to prevent high levels of nitrosamine impurities in their products. Read More
When the FDA is reviewing products that include both drugs and devices in combination, a stumbling block that sometimes causes delays is poor communication between the agency's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH), according to an independent assessment by Lexington, Mass.-based Eastern Research Group (ERG). Read More
The chair of the House Committee on Oversight and Reform has told her colleagues that she is issuing a subpoena to AbbVie as part of the committee’s ongoing investigation into how companies set drug prices. Read More
In a widely reported interview over the weekend, FDA Commissioner Stephen Hahn said the agency is prepared to issue an Emergency Use Authorization for a COVID-19 vaccine before phase 3 trials are complete if the benefits outweighed the risks. Read More
The FDA has been accused of potentially fouling up its Aug. 23 Emergency Use Authorization (EUA) of convalescent plasma (CCP) for the treatment of COVID-19 by adding a requirement that each unit of plasma include information on the concentration of antibody titres. Read More
The European Commission announced Monday that it is participating in the World Health Organization’s international COVAX program for COVID-19 vaccines and is contributing $478 million. Read More
Two COVID-19 vaccine candidates being developed by Chinese pharma companies have already received emergency authorization in China, the country’s National Medical Products Administration (NMPA) revealed. Read More
The UK has unveiled a proposal that would empower the Medicines and Healthcare Products Regulatory Agency (MHRA) to temporarily authorize effective COVID-19 vaccines while they are still under review. Read More
HHS denied Friday that its termination of a prominent public relations consultant had anything to do with the recent controversy over the FDA Commissioner’s presentation on convalescent plasma as a COVID-19 treatment, while the FDA refused to shed any light on the reported firing of its head spokesperson. Read More
The FDA has detailed how the agency’s Office of Generic Drugs (OGD) will handle requests for drug application ownership transfers in a new manual of policies and procedures (MAPP). 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