Either way, there’s a good chance that these labels — the detailed instructions for use that accompany every drug approved by the Food and Drug Administration — are out of date and lacking ...

The rule would overturn regulations that have been in place for three decades that prohibit generic drugmakers from updating safety data on their labels without such changes first being made by ...

When new evidence emerges that a brand-name prescription drug has harmed patients, manufacturers are required to immediately warn doctors and consumers by updating product labels or sending letters.

SACRAMENTO, Calif. – California could become the first state with its own prescription drug label under a proposal Gov. Gavin Newsom unveiled Thursday. Newsom wants California, home to nearly 40 ...

Supreme Court set to consider cert. petition on generic drug use of “skinny labels” to avoid infringing method of use patents. Court expected to consider cert. petition during court conference ...

The Times objects to a Food and Drug Administration proposal to allow generic drug manufacturers to update safety labeling to warn of newly discovered risks, as brand-name manufacturers have long ...

In a recent post, I noted the Catch-22 that the Supreme Court insists Congress created with its fast-track approvals for generic drugs. Those who are injured by a brand-name drug can win ...

published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn for reasons other than ...

When a doctor prescribes a drug off-label, they are prescribing it for a different condition or at a different dosage than the FDA have approved. Off-label prescribing is common. According to the ...

WASHINGTON, Feb 28 (Reuters) - Generic drugmakers are furiously campaigning against a proposed U.S. rule that would require them to change the prescribing information on their products if they ...