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The FDA’s Office of Prescription Drug Promotion issued an untitled letter to Pfizer for a misleading direct-to-consumer online video for its Estring (estradiol vaginal ring) treatment for moderate-to-severe painful sex and vaginal discomfort after menopause. Read More
The Federal Trade Commission is taking a victory lap after a federal judge ordered AbbVie to pay a record $448 million antitrust award over its handling of a testosterone replacement gel. Read More
CDER launched two new efforts to gather feedback about the use of quality metrics in modernizing drug quality systems, calling for participants in a voluntary pilot program and encouraging meeting requests. Read More
The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements. Read More
The U.S. Supreme Court agreed to hear Merck’s appeal of a ruling allowing hundreds of failure-to-warn lawsuits against the drugmaker to proceed. Read More
In the wake of hundreds of healthcare fraud arrests by the Justice Department last week, FDA Commissioner Scott Gottlieb promised more inspections of compounding and outsourcing facilities that distribute products without a valid medical need. Read More
Sponsors are assessed BPD fees when they enter the initial product development program. They also must pay an annual BDP fee at the beginning of each fiscal year as long as the product remains in active development. Read More
The agency defines a therapeutic radiopharmaceutical as any product that contains a radionuclide and is used in patients with cancer for treatment of the disease or for palliation of tumor-related symptoms such as pain. Read More