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The FDA is getting closer to releasing a guidance that will address the scientific challenges in creating generic biologics and provide a foundation for a possible legal and regulatory framework for approving the complex treatments.
Companies are taking a calculated risk if they choose to present off-label trial data on their websites, since this is an area in which the FDA has declined to issue a guidance.
As part of the Bush administration’s effort to curb widespread abuse of prescription painkillers, the FDA and the Drug Enforcement Administration (DEA) are developing new, more explicit labeling guidelines for manufacturers of controlled substances like Purdue Pharma’s OxyContin and Abbott Laboratories’ Vicodin.
The FDA has revised its guidance for combined oral contraceptives and instructed manufacturers to simplify patient labeling sections and incorporate more clinical trial data in their labeling.
To ensure drugmakers submit appropriate data and avoid product development delays, the FDA should distinguish between valid and probable biomarkers and develop minimum data standards in its final pharmacogenomics (PGx) guidance, according to industry comments submitted to the agency.
Some 48 members of Congress have sent FDA Commissioner Mark McClellan a letter urging him to approve OTC status for the emergency contraceptive Plan B before leaving his current post to take the reins at the Centers for Medicare & Medicaid Services.
The FDA's Office of Combination Products met the time requirement for assigning combination products to agency centers in 100 percent of the requests it received over a seven-month period, the office said in its first annual report to Congress.
The FDA has warned Texas-based manufacturer Osteomed that it will no longer process premarket applications (PMA) submitted by the firm until numerous quality failures associated with the company’s surgical devices are resolved.
The U.S., Canada and Mexico have signed a trilateral agreement establishing a supervisory body to combat health fraud, boost emergency preparedness and promote the exchange of information on devices, drugs and other healthcare products.
The failure of a U.S. cardiac monitor manufacturer to document the most basic elements of design and quality control in its medical device reporting has attracted the FDA’s attention.