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The FDA is taking steps to introduce more regulatory flexibility into postmarket reviews in order to get industry’s support for the agency’s Quality by Design (QbD) initiative, officials said.
In recent years, the FDA has increasingly moved to a risk-based model for evaluating pharma and biotech manufacturers, who are assigned site risk potential (SRP) scores.
The FDA is taking steps to introduce more regulatory flexibility into postmarket reviews in order to get industry's support for the agency's Quality by Design (QbD) initiative, officials said.
The FDA has issued a new guidance to help makers of cell-based viral vaccines improve the development and availability of vaccines, including those to address emerging and pandemic threats.
The FDA issued the final version of its comprehensive current good manufacturing practice (cGMP) guidance Sept. 29, making "no substantive changes" from the draft released two years ago, the agency said.
The FDA seems likely to appeal a federal district court’s decision on drug compounding after the court rejected the government’s motion to amend its earlier decision, sources say.
Icelandic generic drugmaker Actavis failed to conduct a follow-up investigation of a fatal adverse event, did not submit required reports on adverse drug experiences (ADEs) to the FDA and "manufactures numerous prescription drug products without approved applications," the agency said in a warning letter to the firm.
The head of Vietnam’s Pharmaceutical Management Department (PMD), Cao Minh Quang, announced last month that pharmaceutical manufacturers in Vietnam must meet international standards on drug production or face closure.
After winning a lawsuit against the FDA, Utah Medical Products is taking another step in its battle with the agency, filing a petition with HHS Aug. 8 saying the FDA should remove a two-year-old press release about the firm from its website.