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The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
As Pfizer and Moderna prepare to file for Emergency Use Authorization for their promising COVID-19 vaccines in the coming weeks, they will face unprecedented distribution challenges – in Pfizer’s case the need to hold the doses at super-cold temperatures. Read More
Pfizer announced that it has launched a delivery and distribution pilot program for its COVID-19 vaccine in four U.S. states to determine how to handle challenges posed by the candidate’s ultra-low temperature requirements. Read More
The FDA has updated its final guidance on the use of convalescent plasma in COVID-19 treatment and clinical trials, extending its enforcement to Feb. 28, 2021. Read More
Indivior Solutions, the maker of suboxone — a drug approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment for opioid-use disorder — was sentenced last week to pay $289 million in criminal penalties for unlawful marketing of an opioid drug. Read More
The HHS Office of Inspector General (OIG) has issued a warning to drugmakers to avoid paying kickbacks in the form of payments for speaker programs. Read More
Companies that have developed a COVID-19 vaccine that is approved in the European Union will have to submit monthly safety reports during the pandemic to the European Medicines Agency (EMA), the agency said. Read More
The EMA’s outgoing head, Guido Rasi, welcomed Cooke as “a strong leader who is committed to steering EMA during this very challenging period.” Read More
The drugmakers also finalized an agreement with the European Commission this week to supply 300 million doses of their vaccine starting by year’s end. Read More
President Trump said Friday that his administration is “working to secure an Emergency Use Authorization” from the FDA for Pfizer’s vaccine candidate for COVID-19 and that it will be available to the general population for free “as soon as April,” but will be withheld from states like New York whose governors have expressed qualms about a vaccine approved by the FDA under the current administration. Read More
The Senate Appropriations Committee has released the draft of a bill that would grant the FDA $3.2 billion in fiscal 2021 funding — an amount that mirrors what the House allocated in July and is in line with the Trump administration’s budget request for the agency. Read More
Democrats in both the House and Senate have penned letters to the Department of Justice protesting its $8.3 billion settlement with Purdue Pharma that would see the beleaguered opioid maker become a public benefit company as it emerges from bankruptcy over its role in the opioid crisis. Read More