Compliance Regulations and Guidance Affecting your Industry

Current Good Manufacturing Practice for Medical Gases

The FDA recently amended its CGMP (current good manufacturing practice) and labeling regulations for medical gases. The agency requires that portable cryogenic medical gas containers that are not manufactured with a permanent gas use outlet connection must have gas-specific use outlet connections that cannot be removed nor replaced, except by the manufacturer.

FDA also requires that portable cryogenic medical gas containers as well as high pressure medical gas cylinders adhere to stipulated naming, labelling, and color requirements.

FDA's Revised Guidance on Submission of Quality Metrics Data

Quality metrics are a key component for the pharmaceutical and biologics industry to monitor the quality control system and process in their manufacturing procedures. These metrics are helpful for FDA to develop inspection policies and practices for drug manufacturers and to inspire the industry to implement up-to-date, advanced quality management systems for pharmaceutical manufacturing.

FDA Guidance on Infant Formula Labeling

The US FDA oversees manufacturers and distributors of infant formulas and helps ensure that these products are safe for infants who consume them. In line with this mission, FDA has released its final guidance on labeling requirements for infant formula products.

The guidance aids manufacturers and distributors of infant formula products to comply with labeling requirements including requirements related to the statements of identity, exempt infant formula and nutrient content claims.

Assessment of Abuse Potential of Drugs - Guidance for Industry

Abuse-Deterrent Opioids (Evaluation and Labeling) - Guidance for Industry

With the intent to assist applicants who seek approval for a new drug, particularly to evaluate the abuse potential of the drug, and to assist sponsors of investigational new drugs, these FDA guidance seek to offer insight into key decision points such as recommended studies in assessing abuse potential, cases when abuse-related studies should be conducted, preparing the NDA submission, NDA review and product labeling related to abuse potential, and the drug scheduling process.

How to Comply with FDA’s Voluntary Qualified Importer Program?

FDA's Voluntary Qualified Importer Program (VQIP), one of the key requirement of the Food Safety Modernization Act (FSMA), is aimed to expedite the reviewing and importing process of foods from certified facilities. In November 2016, FDA published its final guidance that details how the VQIP will work.

FDA Guidance on cGMP Requirements for Combination Products

The US regulatory pathway for combination products is not always very clear. As combination products include constituents that would normally be regulated under different types of governing authorities, they raise regulatory, policy, and review management challenges.

US FDA has recently issued a final guidance detailing the cGMP requirements for combination products including drug-drug, drug-device, device-biologic or drug-biologic combination products. The guidance follows the 2013 final rule on cGMP requirements for combination products.

FDA Guidance on Clinical Pharmacology Section of Drug and Biological Product Labeling

The clinical pharmacology section of the label should provide an information that is understandable and clear to health care professionals who may not have specific expertise in clinical pharmacology. The FDA guidance offers recommendations for preparing the clinical pharmacology section of prescription drug labeling for applicants submitting NDAs, supplements to approved NDAs, ANDAs, biologics license applications (BLAs) and supplements to BLAs.

FDA Guidance on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

The conduct of clinical trials are monitored through variety of approaches that differ between businesses, government organization, and educational institutions. Considering this variability, the FDA guidance describes the risk based strategy for monitoring, including the use of on-site monitoring, centralized monitoring, and additional alternative monitoring techniques

FDA Guidance on Clinical Investigator Roles and Responsibilities

Investigators conducting the clinical trials should meet all research expectations including FDA requirements and Good Clinical Practice (GCP) guidelines. Investigators must be diligent throughout the conduct of the trial from designing the protocol, determining which trials to perform, during the conduct and after completion of the study.

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance

Pharmacovigilance plays a pivotal role in safeguarding ongoing safety of drug products. It is impossible to recognize all safety concerns during clinical trials. Once a drug is marketed, it is usually exposed to a large number of patients including those with co-morbid conditions.

Post marketing safety drug monitoring includes finding of drug interactions, evaluating the influence of inactive ingredients to the safety profile, methods for comparing safety profiles of similar drugs, investigation of the adverse effects on human health of drug residues in animals, e.g. antibiotics and hormones.

Quality Agreements: Contract Manufacturing Arrangements for Drugs

Drug manufacturers who use contract facilities now have final guidance from the FDA on quality agreements. Consequently, the drug makers and contractors need to review their existing agreements to ensure compliance with the final requirements.

General Principles of Software Validation

Software validation is a vital tool used to assure the quality of software and software automated operations for medical devices. Software validation can increase the reliability and accuracy of the device, subsequently leading to fewer recalls and corrective actions, less risk to patients, decreased failure rates, and reduced liability to device manufacturers.

The FDA guidance details the general validation principles that are appropriate to the validation of device software or the validation of software used to design, develop, or manufacture medical devices.

Implementing Design Controls for Device Manufacturers

Design controls are a part of an inclusive quality system that covers the life of a device from the development of device requirements through design, production, distribution, use, maintenance, and ultimately, obsolescence. Design control also applies to the changes to the process design including those occurring after a device has been offered to the market.

This guidance document applies to the design of the medical devices including new designs as well as changes to the existing device designs.

Providing Regulatory Submissions in Electronic Format — Receipt Dates

This FDA guidance document is intended to aid sponsors, applicants and others making regulatory submissions to FDA in electronic format. The guidance details how FDA will allocate receipt dates to regulatory submissions to the CDER and CBER for drug products.

cGMP Guidance: Sterile Drug Products Produced by Aseptic Processing

This guidance is proposed to aid manufacturers of sterile drug and biological products meet the FDA cGMP requirements when manufacturing these products under aseptic processing. This guidance replaces the 1987 Industry Guideline on Sterile Drug Products Produced by Aseptic Processing.

Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products

The FDA has established recommendations and regulations to ensure sanitary and safe processing of seafood (fish and fishery products), which includes imported seafood. These regulations mandate applying the HACCP (Hazard Analysis Critical Control Point) principles for seafood processing. A preventive system of hazard control, the HACCP principles can be used by food processors to establish the safety of their products for consumers.

ICH Q10 Pharmaceutical Quality System

Referred to as the pharmaceutical quality system, this internationally harmonized guidance is defined to assist pharmaceutical manufacturers by describing a model for an effective quality management system. In this guidance, the ICH Q10 model is referred to as the pharmaceutical quality system.

E2E Pharmacovigilance Planning Guidance

This Pharmacovigilance planning guidance is intended to aid in planning pharmacovigilance activities, especially in preparation for the early post marketing period of a new drug. The main focus of this Guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of licence application.

Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments

The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. GDUFA requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.

Cosmetic Good Manufacturing Practices Guidance

The FD&C Act prohibits the introduction, or delivery for introduction, into interstate commerce of cosmetics that are adulterated or misbranded.

Tampering and other malicious or unlawful activity present additional risks that can also have a direct impact on products’ quality. To help minimize these risks to cosmetics, FDA recommends to consult a separate FDA guidance document entitled “Guidance for Industry: Cosmetic Processors and Transporters of Cosmetics Security Preventive Measures Guidance.