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The FDA has reopened the comment period for a notice on time estimates for collecting information for reporting manufacturing changes on approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs), citing a lack of industry input.
As part of an ongoing effort to help firms improve the quality of their generic drug applications, the FDA’s Office of Generic Drugs (OGD) will soon post a dissolution-methods database on its website and start updating the Orange Book daily.
More than half of the participating product review divisions in the FDA's Center for Drug Evaluation and Research (CDER) are still accepting submissions for a pilot program that will assess the effectiveness of continuous marketing applications for fast-track designated drugs, the agency announced recently.
In a final rule that is expected to cost the drug industry $28.1 million in the first two years of implementation, the FDA is requiring drugmakers to include linear bar codes on the labels of most prescription drug products commonly used in hospitals and other healthcare settings.
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.
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.
Makers of combined oral contraceptives (OCs) should simplify patient labeling sections and incorporate more clinical trial data in their labeling, according to a recently revised FDA guidance for the products.
The FDA needs to clarify the distinction between valid and probable biomarkers and develop minimum data standards in its final pharmacogenomics (PGx) guidance to ensure drug manufacturers submit the appropriate data and avoid delays in product development, according to industry comments received by the agency recently.
To help lighten the paperwork load associated with product safety information requests, the FDA is encouraging drugmakers to use summary bridging reports (SBRs) when regulatory authorities seek safety data spanning beyond a single periodic safety update report (PSUR).