CDER Planning Multiple Generics Guidances in 2021, Agenda Reveals
The FDA’s Center for Drug Evaluation and Research (CDER) has released its list of planned new and revised guidances for calendar year 2021, an agenda that includes a large number…
CDER Hit Most Review Targets in 2020 Despite Pandemic Obstacles
Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last…
Hacked Documents on COVID-19 Vaccines Were ‘Manipulated,’ EMA Says
Internal European Medicines Agency (EMA) documents on pending approvals of COVID-19 vaccines were hacked and leaked online, the agency said last week. Source: Drug Industry Daily
FDA More Selective About Convening Advisory Committee Panels During Pandemic
FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving…
Report Touts FDA’s Actions in Responding to the Pandemic
The COVID-19 pandemic has brought out many of the FDA’s strengths, including its commitment to science-based decisionmaking, according to a new report on the agency’s Pandemic Recovery and Preparedness Plan…
Medicare Pays Twice as Much as VA for Many Drugs, GAO Finds
Medicare Part D pays twice as much on average for hundreds of drugs as the Department of Veterans Affairs (VA), mostly because VA negotiates prices directly with drugmakers, the Government…
Most FDA Approved Novel Drugs in 2020 Went Through Accelerated Reviews
Most of the 53 novel drugs approved by the FDA in 2020 were reviewed through at least one expedited approval process, the agency said in a report on the year.…
Trio of Drugmakers File Lawsuits Against HHS Over 340B Discounts
AstraZeneca (AZ), Sanofi and Eli Lilly have each filed lawsuits against HHS, arguing the federal government can’t force them to provide 340B drug discounts to contract pharmacies. Source: Drug Industry…
HHS Issues Final Rule Imposing Renewable Term Limits for FDA Directors
Another last-minute Trump administration policy was issued at the end of last week by HHS that requires five-year, renewable term limits for directors of all agencies under the department, including…
Moderna Will Evaluate Booster Shot for COVID-19 Vaccine in New Trial
Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot through a new clinical trial in…
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