Washington Drug Letter

The FDA should work with other regulatory bodies, especially the European Medicines Agency (EMA), to create a single marketing application that would be accepted by multiple regulators, drug industry insiders urge.

Some Democratic lawmakers are pushing for a drug pedigree system to combat potential “gray marketing” of shortage drugs, arguing that a national track-and-trace system would not be enough to secure the supply chain.

The FDA has tapped Gerald Dal Pan, the acting director of the newly reorganized Office of Surveillance and Epidemiology (OSE), to head up the office permanently, agency officials say.

Succinct, simply worded standard operating procedures (SOPs) that can be expressed in cartoon or flowchart format lead to higher rates of compliance, pharma experts say.

Novo Nordisk will have to wait until late October to get word on the fate of two ultra-long-acting insulin treatments because the FDA needs additional time to review data clarifications and analyses it requested after the initial NDA submissions.

Biologics, like small-molecule drugs, may soon be subject to early shortage notification requirements if a group of stakeholders convinces lawmakers to include them in the pending user fee authorization bill. 

Drugmakers can help secure the global supply chain from counterfeits and cargo theft by mapping their network of suppliers to better assess their risks and prioritize mitigation, industry groups say.

The FDA has approved Roche subsidiary Genentech’s Perjeta as part of a first-line treatment combination for patients with HER2-positive metastatic breast cancer.

The FDA has informed Gilead Sciences it needs at least three more months to weigh its Truvada sNDA for HIV prevention, AIDS advocates say.

The FDA’s Office of Generic Drugs (OGD) appears to be taking the first steps to whittling down its almost 3,000-long ANDA backlog, telling drugmakers it will discard 364 pending generic-drug applications unless told otherwise.