Tag: Biohaven

Biohaven

Regulatory/FDA

Two Recent OPDP Letters Prompted by “Bad Ad Program” Complaints

Two Recent OPDP Letters Prompted by “Bad Ad Program” Complaints

March 15, 2021 – The FDA Office of Prescription Drug Promotion (OPDP) marked the 10-year anniversary of the Bad Ad Program in 2020, and kicks off 2021 with three enforcement actions – two Warning Letters and one Untitled Letter – two of which cited the Bad Ad Program as the source of complaints about potentially […]

Read more

Regulatory/FDA

COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines

COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines

April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]

Read more