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In his first presidential news conference yesterday, President Biden set a new goal of 200 million COVID-19 vaccinations by his 100th day in office — doubling his initial goal. Read More
The FDA has revised its fiscal 2021 user fee rates for the Over-the-Counter (OTC) Monograph Drug User Fee Program to reflect exemptions for alcohol-based hand sanitizer makers, noting that OTC drugmakers will see an increase in facility fees. Read More
As Europe continues to face challenges and setbacks in its COVID-19 vaccination efforts, the European Commission (EC) has proposed new criteria for vaccine export authorizations to conserve its supplies. Read More
Democrats are reportedly considering using budget reconciliation, a procedure that would allow them to bypass Republican opposition and filibustering, to get major drug pricing legislation to the president’s desk. Read More
Amy Abernethy, the FDA’s principal deputy commissioner and acting chief information officer, will depart from the agency in a matter of weeks, according to acting commissioner Janet Woodcock. Read More
The Center for Drug Evaluation and Research (CDER) highlights efforts to deal with drug shortages, sham COVID-19 products and poorly compounded drugs, as well as its enforcement successes amidst the pandemic, in its latest annual report from its Office of Compliance, released yesterday. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to resume in-person inspections of drug facilities starting March 29 but it will adopt a hybrid approach that allows for both remote and on-site elements. Read More
The European Medicines Agency (EMA) has advised against the use of Merck’s anti-parasitic drug Stromectol (ivermectin) for the prevention and treatment of COVID-19. Read More
As the EU’s COVID-19 vaccine supply woes intensify, the 27-member bloc is signaling it could make good on its threat to halt exports of vaccine doses to the UK as soon as this week. Read More