March 2019 Drug and Device Corner

Implementation of reorganization to begin for CDRH

In order to create a smart and quick-moving infrastructure that can adapt to the needs of future organizational, regulatory and scientific requirements, the Center for Devices and Radiological Health (CDRH) is beginning the implementation of a reorganization. 

The reorganization will integrate CDRH’s premarket and post-market program functions along product lines, allowing their experts to leverage their knowledge to optimize decision-making across the product life cycle. This type of approach blends many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach. With the implementation of reorganization, the FDA aims to enhance information-sharing across the Center, increase collective decision-making, improve work-life balance and increase professional opportunities for employees.

The implementation is set to begin March 2019 and is expected to be completed by September 2019. FDA says the implementation will take place in a phased approach, and timelines for implementation will vary by office. Each office within the current CDRH structure is undergoing some change in order to better support and advance CDRH’s public health mission and vision.

More information can be found here.

CDER:

Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis

Severely Debilitating or Life- Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Quality Considerations for Continuous Manufacturing

Bioavailability Studies Submitted in NDAs or INDs — General Considerations

Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations

Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products

CDER & CBER:

Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling

Rare Diseases: Natural History Studies for Drug Development

Pediatric HIV Infection: Drug Product Development for Treatment

Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products

Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies

Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients

Cancer Clinical Trial Eligibility Criteria: Brain Metastases

Nonproprietary Naming of Biological Products: Update

CDRH & CBER:

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

Refuse to Accept Policy for 510(k)s

CDRH:

Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)

Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations

CBER:

Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research

Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format

All Centers:

A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers

Posted in Drug and Device Corner, Drugs, Medical Devices.