Department of Health and Human Services February 27, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Quality Considerations for Continuous Manufacturing.'' This draft guidance provides information regarding FDA's current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER). The draft guidance describes several key quality considerations and provides recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small molecule, solid oral drug products that are produced via a continuous manufacturing process. FDA supports the development and implementation of continuous manufacturing for drug substances and all finished dosage forms where appropriate, including those submitted in NDAs, ANDAs, drug master files, biologics license applications (BLAs), and nonapplication over the counter products. Scientific principles described in this draft guidance may also be applicable to continuous manufacturing technologies used for these drugs. However, this draft guidance is not intended to provide recommendations specific to continuous manufacturing technologies used for biological products under a BLA.

The Agency for Healthcare Research and Quality (AHRQ) is announcing a Special Emphasis Panel (SEP) meeting on AHRQ-HS-18-002, ``Screening and Management of Unhealthy Alcohol Use in Primary Care: Dissemination and Implementation of PCOR Evidence (R18).''