EAS would like to remind clients, the FDA FY 2019 establishment registration renewal period begins this month. With reference to Drug Establishments, please make sure you are aware of your obligations under the Drug Supply Chain Security Act (DSCSA) during this drug listing certification period. The FDA has released several guidance documents to assist.
In the event you not already seen the Statement from FDA Commissioner Scott Gottlieb, M.D, EAS highly recommends you read this to understand the FDA’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities. The statement includes a link to the FDA’s published internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections.
In addition, FDA recently announced a Special 510(k) Program Pilot, which aims to expand upon the types of changes eligible for the Special 510(k) Program to improve the efficiency of 510(k) review. FDA is working to simplify the review of certain 510(k)s for industry and FDA staff using efficient practices consistent with least burdensome principles. As part of this pilot, certain design or labeling changes that previously were reviewed as a Traditional 510(k) may be eligible to be reviewed through the Special 510(k) pathway instead. The Agency believes that the reliance on design control requirements and previous Agency review of detailed information can reduce review times and still protect the public health. This pilot is part of ongoing efforts to simplify the 510(k) process and help promote timely access to safe, effective, and high-quality medical devices. EAS offer 510(k) review and submission assistance. Please contact us for more information.
Guidance Document updates on the FDA website:
Postapproval Changes to Drug Substances
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers
Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
Allergic Rhinitis: Developing Drug Products for Treatment
Nonallergic Rhinitis: Developing Drug Products for Treatment
Physiologically Based Pharmacokinetic Analyses — Format and Content
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development
Technical Specifications—Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications
FDA Product-Specific Guidances for Generic Drug Development webpage
FDA in Brief: FDA issues 54 product-specific guidances to promote generic drug access and drug price competition
CDER & CBER:
Hematologic Malignancy and Oncologic Disease: Considerations for User of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing
Recognition and Withdrawal of Voluntary Consensus Standards
510(k) Third Party Review Program
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
Posted in Drug and Device Corner, Drugs, Medical Devices.