September 2018 Drug and Device Corner

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:

All centers:

Postapproval Changes to Drug Substances

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

CDER:

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

CDRH:

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.