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As part of its forward-looking initiative to drive greater use of real-world evidence (RWE), the FDA has issued detailed guidance for sponsors and researchers who intend to use electronic health records (EHRs) and medical claims to support drug approvals and post-approval requirements. Read More
The Cherokee Nation territory in Oklahoma has reached a settlement of $75 million with the three largest drug wholesalers in the U.S. over their alleged role in the opioid epidemic. This is the first settlement with a tribal government in the opioid litigation. Read More
In a rare move, the FDA has informed multiple drug sponsors that used two Indian contract research organizations (CROs) with concerning data integrity practices that the bioequivalence or bioavailability studies those firms conducted will need to be repeated elsewhere. Read More
The FDA has laid out its draft recommendations for designs, study populations and endpoints for clinical trials of drugs designed to treat naïve and refractory nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC). Read More
What type of notification the FDA will provide to a drug or biologics company that may not be complying with good manufacturing practices (GMP) depends on several factors, including the type of problem, the law and the agency’s internal regulatory procedures manual, agency officials said yesterday at the FDA/Parenteral Drug Association (PDA) joint regulatory conference. Read More
Eli Lilly has announced that it will drop the list price of its Insulin Lispro Injection by 40 percent in the U.S. as of Jan. 1, bringing the drug’s list price down to 2008 levels. Read More
Acting FDA Commissioner Janet Woodcock outlined the FDA’s proposed commitments to industry under the next iteration of the Prescription Drug User Fee Act (PDUFA) — and pledged to support enhanced reviews of emerging biotherapeutics — during a virtual public meeting held yesterday. Read More
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, has let his staff know that he is now also acting director of the agency’s Office of Vaccines Research and Review (OVRR) as its two top officials prepare to retire this fall. Read More
Under the 340B program, pharmaceutical manufacturers extend lower pricing to hospitals and clinics that treat significant numbers of low-income patients. Read More
The risks have been well-known for years, but the Department of Defense has neither assessed them nor solved any of the problems they present, the document notes. Read More