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The FDA’s Florida District office has placed Andrx’s pending abbreviated new drug applications (ANDAs) on hold due to manufacturing problems — a move that could potentially threaten the generic firm’s portfolio of previously approved drugs.
Chiron has made significant strides to bring its Liverpool, England, manufacturing plant into compliance with U.S. standards, but the embattled vaccine manufacturer still needs to make additional improvements before it can return its influenza vaccine, Fluvirin, to the U.S. market, the FDA said.
With the current emphasis on drug safety, it's more important than ever for pharmaceutical companies identify and evaluate their risk management strategies early in the drug development process and plan to continue that scrutiny through the life of the compound, according to an industry expert.
The saga of troubled generic drugmaker Able Laboratories took yet another turn this month when the company said it intends to sell its assets — a move sparked by the FDA’s rejection of a consent decree proposal that would have allowed the firm to relaunch its withdrawn drug products without having to resubmit abbreviated new drug applications (ANDAs).
The FDA’s Office of Generic Drugs (OGD) has launched an initiative to revamp its chemistry, manufacturing and controls (CMC) review process for abbreviated new drug applications (ANDAs) — a project the agency said will improve application review times and reduce the number of CMC supplements that manufacturers must submit.
Looking to make another big splash on the acquisitions front, Novartis has offered $4.5 billion in cash for the remaining shares of California-based vaccine maker Chiron.
Chiron has made significant strides to bring its Liverpool, England, manufacturing plant into compliance with U.S. standards, but the embattled vaccine manufacturer still needs to make additional improvements before it can return its influenza vaccine, Fluvirin, to the U.S. market, the FDA said.
The FDA is hosting a series of workshops in China aimed at educating participants on methods for complying with current good manufacturing practices (cGMP).