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The FDA is expected to approve 34 new drugs this year, down from a record 43 approved in 2012. That drop is expected to be temporary, though, as more drugmakers adjust their pipelines to take advantage of the agency’s breakthrough therapy pathway. Read More
The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More
Senior European Medicines Agency (EMA) officials are cautioning their peers that when it comes to making regulatory decisions, high levels of risk aversion may do more harm than good. Read More
Drugmakers should establish a company task force of upper management and quality personnel to prevent drug shortages, according to new good practice guidelines developed by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Read More
Certain drug and biologic manufacturers must notify the FDA at least six months before they believe a product may be permanently discontinued or experience an interruption in manufacturing, according to a new proposed rule announced last month. Read More
While the number of FDA inspections of clinical investigators has grown in the last 30 years, the proportion of objectionable findings has dramatically decreased, says a new report. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More
More than three years after Hospira’s Rocky Mount, N.C., plant was warned for lax quality control, prompting a painful manufacturing slowdown and a costly remediation, the drugmaker expects to near the “top end” of production capability in 2014, Hospira’s chief said Nov. 6. Read More
The FDA has handed Daiichi Sankyo an untitled letter for making claims in a brochure that two of its hypertension treatments helped lower blood pressure in patients with severe hypertension, despite a lack of substantial supportive evidence. Read More
A California judge has ruled that Sandoz must file an application with the FDA for approval of a biosimilar referencing Amgen’s biologic arthritis drug Enbrel before it can challenge the brand drug’s patents. Read More
The FDA may extend comment deadlines for certain drug-related regulations and guidance because the system through which online comments are submitted, Regulations.gov, was down for several days earlier this month. Read More
The Government Accountability Office (GAO) has been asked by a bipartisan group of six senators to analyze and report on current federal activities impacting regenerative medicines. Read More