Compliance Regulations and Guidance Affecting your Industry

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 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

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.

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.

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.

FDA Guidance Q9 on Quality Risk Management

Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In recent years, the importance of quality systems has been recognized in the pharmaceutical industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system.

Draft Guidance: Data Integrity and Compliance with cGMP

US FDA has lately observed increased cGMP violations involving data integrity during inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related cGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.

Non-prescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act. A report of each adverse drug experience which is both serious and unexpected must be made to the Agency, as soon as possible, but no later than 15 days, after receiving information about the event.

In 2011, according to FDA, as many as 250 drug shortages have been traced, and a total of 195 drug shortages were prevented, as the Agency has taken proactive steps needed to increase available supply for patients in the U.S. The FDA recently released new guidance on how manufacturers can notify authorities on impending drug shortages.

On February 9, 2012, the FDA released draft guidelines about quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.

On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.

On December 27, 2011, the FDA released new draft guidance on 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications. The guidance aims to explain the decision-making process of FDA for determining substantial equivalence and provides additional details about the regulations, strategies, and norms upon which the FDA’s review of the 510(k) application is based. The guidance also provides information about new policies regarding Special 510(k) and Abbreviated 510(k) submissions to FDA.

The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials. Aimed at medical device manufacturers and developers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.