The FDA has published a list of upcoming regulations it plans to issue in the next year. The complete list is available here. Of these regulations, following is a list that will have relevance for the pharmaceutical and medical device industries:
1. Title: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Abstract: FDA is proposing regulations for preventive controls for animal food, including ingredients and mixed animal feed. This action is intended to provide greater assurance that food marketed for all animals, including pets, is safe.
2. Title: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Second Phase
Abstract: FDA will revise regulations for "current good manufacturing practice" for oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. This revision will update and harmonize requirements and improve detection and response to emerging product safety and quality signals.
3. Title: Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Components
Abstract: FDA will revise regulations for "current good manufacturing practice" with regard to the control over components used in manufacturing finished pharmaceuticals.
4. Title: Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves
Abstract: FDA has determined that a subset of surgeon and patient exam gloves that are powdered and that represent a modest share of the market present a substantial risk of illness that cannot be corrected by a change in labeling. These gloves are Powdered Natural Rubber Latex Surgeon's Gloves, Powdered Synthetic Latex Surgeon's Gloves, Powdered Natural Rubber Latex Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove. Consequently, FDA is proposing to ban these devices.
5. Title: Postmarket Safety Reporting for Combination Products
Abstract: The rule would describe the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biological product). The rule would clarify that a combination product is subject to the reporting requirements associated with the type of marketing application under which the product is approved, licensed, or cleared, and to certain additional, specified reporting requirements depending on the types of constituent parts (drug, device, or biological product) of which it is comprised. The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while minimizing duplicative reporting requirements.
When these regulations are issued, GxP Systems will bring you an in-depth analysis on the impact the revised regulations will have on the pharmaceutical and medical device industries