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USFDA Guidance: Changes to Disposable Manufacturing Materials, Clinical Pharmacology Considerations

Multiple guidances were updated and released by the USFDA last week and had some important updates related to Drugs, Biologics, and Medical devices.


This guidance describes chemistry, manufacturing, and controls (CMC) postapproval changes related to disposable manufacturing materials that applicants can pursue in drug and biological product manufacturing.


This guidance applies to biologics license application (BLA) products licensed under section 351(a) or 351(k) of the Public Health Service Act (PHS Act); human drug products marketed as new drug applications (NDAs) or abbreviated new drug applications (ANDAs) under section 505(b)(1), 505(b)(2), or 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and animal drugs marketed as new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) under section 512(b)(1) or 512(b)(2) of the FD&C Act.


Guidance on General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products


This guidance provides recommendations for neonatal clinical pharmacology studies, whether the studies are conducted pursuant to section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 505B of the FD&C Act, or neither. Effectiveness, safety, or dose-finding studies in neonates involve assessing clinical pharmacology information, such as information regarding a product’s pharmacokinetics (PK) and pharmacodynamics (PD) to inform dose selection and individualization.


This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations.

Some of the other important guidance released by USFDA this week are

  1. Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices

  2. Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

  3. Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations

FDA Publishes One-Year Progress Report on the Generic Drug Cluster

Also, FDA’s Office of Generic Drugs published its first progress report on the activities and accomplishments of the Global Generic Drug Affairs program’s Generic Drug Cluster.


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