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Drugmakers requested by a regulatory authority to file product information that spans several periodic safety update reports (PSURs) should file a summary bridging report (SBR), the FDA announced in a final International Conference on Harmonisation (ICH) guidance released last week.
An FDA mandate requiring companies to switch to a new file format when submitting drug-label changes will almost certainly cause some short-term pain for the industry, but that should be offset by long-term gains in flexibility and uniformity, according to some industry experts.
The FDA is urging the makers of hormone therapy (HT) products to update their labeling to include data from a clinical study that found women over 65 had an increased risk of dementia when taking oral conjugated estrogens plus medroxyprogesterone acetate.
Switching to a new file format required by the FDA to submit drug-label changes will almost certainly cause some short-term pain for the industry, but that should be offset by long-term gains in flexibility and uniformity, some industry experts say.
Enforcement provisions of a U.S.-European Union (E.U.) framework covering data privacy may be giving U.S. drug companies pause when it comes to safe harbor certification, despite the profound impact that European legal constraints on transferring personal data could have on those companies, according to industry experts.
The FDA’s current pharmacogenomics draft guidance needs to include guidelines on the conditions and types of studies or study designs that would warrant DNA/RNA collection, Johnson & Johnson (J&J) told the agency recently in comments on the draft guidance.
Drugmakers requested by a regulatory authority to file product information that spans several periodic safety update reports (PSURs) should file a summary bridging report (SBR), the FDA announced in a final International Conference on Harmonisation (ICH) guidance released yesterday.
Drugmakers’ general disease awareness communications must be perceptually distinct from promotions of specific drugs or the awareness information will be subject to FDA rules governing promotional labeling and advertising, the agency said in a draft guidance yesterday.
Drug manufacturers may be able to cut advertising costs -- and better educate consumers -- if they adopt recommendations contained in one of two draft guidances on direct-to-consumer advertising released by the FDA yesterday, agency officials said.
Manufacturers considering submitting an abbreviated new drug application for clozapine tablets should conduct in vitro dissolution testing on 12 dosage units of the test product against the 12 units of the reference unit, and report the percent of each unit dissolved, according to a recently released FDA draft guidance.