Compliance Regulations and Guidance Affecting your Industry

This guidance is intended to assist applicants in deciding:

(1) what studies should be included in the CLINICAL STUDIES section of prescription drug labeling,

(2) how to describe individual studies, and

(3) how to present study data, including presentation of data in graphs and tables.

The FDA-prescribed adverse reactions section makes it easier for healthcare practitioners to identify adverse reactions that are most important for prescribing decisions.

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

In October 2011, the FDA issued final guidance on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drugs and Biological Products. The aim of the guidance is to help ensure that labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

This document is intended to clarify for FDA personnel and the regulated industry how the agency intends to prioritize its enforcement efforts regarding the pedigree requirements in 21 U.S.C. 353(e)(1)(A) and 21 CFR Part 203 during the first year after the effective date of 21 CFR §§ 203.3(u) and 203.50.

The Prescription Drug Marketing Act aimed at amending the Federal Food, Drug, and Cosmetic Act to ban the reimportation of drugs produced in the United States, to place restrictions on the distribution of drug samples, to ban certain resales of drugs by hospitals and other health care entities, and for other purposes.

An ePedigree or electronic pedigree is an electronic document that satisfies pedigree requirements of prescription drugs. While the FDA hasn’t implemented ePedigree specific regulations for the in the pharmaceutical supply chain, California has formulated laws regarding the use of ePedigrees.

This document serves as a guide to investigators and other FDA personnel inspecting and validating cleaning processes.

It is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable). Simultaneously, one must recognize that for cleaning validation, as with validation of other processes, there may be more than one way to validate a process. In the end, the test of any validation process is whether scientific data shows that the system consistently does as expected and produces a result that consistently meets predetermined specifications.

This guide is intended to cover equipment cleaning for chemical residues only.

This guidance for industry provides the Agency’s current thinking on how to evaluate out-of-specification (OOS) test results. For purposes of this document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.
 

This guidance applies to chemistry-based laboratory testing of drugs regulated by CDER. It is directed toward traditional drug testing and release methods. These laboratory tests are performed on active pharmaceutical ingredients, excipients and other components, in-process materials, and finished drug products3 to the extent that current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211) and the Federal Food, Drug, and Cosmetic Act (the Act) (section 501(a)(2)(B)) apply. The principles in this guidance also apply to in-house testing of drug product components that are purchased by a firm. This guidance can also be used by contract firms performing production and/or laboratory testing responsibilities. Specifically, the guidance discusses how to investigate OOS test results, including the responsibilities of laboratory personnel, the laboratory phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the laboratory, and the final evaluation of all test results.

This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions.

This guidance addresses new and abbreviated new (human and veterinary) drug application products and specified biologics regulated by CDER and CVM as well as nonapplication drug products. Within this scope, the guidance is applicable to all manufacturers of drug substances, drug products, and specified biologics (including intermediate and drug product components) over the life cycle of the products (references to 21 CFR part 211 are merely examples of related regulation). Within the context of this guidance, the term manufacturers includes human drug, veterinary drug, and specified biologic sponsors and applicants (21 CFR 99.3(f)).

The present guidelines represent an initial consolidated version containing additions, suggestions and corrections from various people representing associations, companies and the field of science. Feedback of any kind is very much welcome and can be submitted to the abovementioned e-mail address. The document will be further revised throughout next year and is scheduled to be replaced by an updated version at the end of 2011.

The safety data sheet (SDS) plays a key role in this respect. On the one hand, it has to enable the processing industry and business in general to recognise potential hazards during the production and manufacturing processes. At the same time, it has to provide the necessary basis to evaluate potential dangers to health and the environment in the finished products.

Based on current knowledge, possible risks from what are known as nano-objects can arise when they are free or when they are released from products.
 

As per the amendment, tests on substances carried out within the framework of this Directive shall be conducted according to the requirements of Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency.

 

 With a view to facilitating worldwide trade while protecting human health and the environment, harmonised criteria for classification and labelling and rules for safety data sheets have been carefully developed over a period of more than 10 years within the United Nations (UN) structure, resulting in the Globally Harmonised System of Classification and Labelling of Chemicals, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is being amended.

This Regulation should ensure a high level of protection of human health and the environment as well as the free movement of chemical substances, mixtures and certain specific articles, while enhancing competitiveness and innovation. This Regulation follows various declarations whereby the Community confirmed its intention to contribute to the global harmonisation of criteria for classification and labelling, not only at UN level, but also through the incorporation of the internationally agreed GHS criteria into Community law.

This document provides technical guidance for MSCAs and manufacturers, importers and downstream users on preparing a CLH dossier under the CLP Regulation. Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures (the CLP Regulation) entered into force on 20 January 2009. The CLP Regulation specifies that Member State2 competent authorities (MSCAs) as well as manufacturers, importers or downstream users may submit proposals for harmonised classification and labeling of substances to the European Chemicals Agency.

Entered into force in June 2007, REACH or Registration, Evaluation, Authorisation and Restriction of Chemicals is a European Union Regulation. As per the REACH guidelines, all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year are mandated to register these substances with a new European Chemical Agency (ECHA) in Helsinki, Finland. The present guidance also addresses the issue of chemical 'substances of very high concern' (SVHC) because of their potential negative impacts on human health or the environment.

This Draft guidance describes the qualification process for drug development tools (DDTs) intended 18 for potential use, over time, in multiple drug development programs. DDTs include, but are not 19 limited to, biomarkers and patient reported outcome (PRO) instruments. The guidance provides 20 a framework for interactions between CDER and DDT submitters.

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current  thinking on this topic . It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Secure and Responsible Drug Disposal Act of 2010 - Amends the Controlled Substances Act to allow an ultimate user of a controlled substance (or, if deceased, any person lawfully entitled to dispose of the ultimate user's property) who has lawfully obtained such substance to deliver that substance to another person, without being registered, for disposal if:

(1) the person receiving the controlled substance is authorized to engage in such activity; and (2) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances.

There have been no internationally accepted objectives or recommendations on the design and conduct of nonclinical studies to support the development of anticancer pharmaceuticals in patients with advanced disease and limited therapeutic options. Hence FDA recently produced a draft guidance whose aim is to establish an internationally accepted objectives /recommendations on how to design and conduct  nonclinical studies for development of anticancer pharmaceuticals in patients with advanced disease and limited therapeutic options.

The purpose of this guidance is to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. This guideline aims to facilitate and accelerate the development of anticancer pharmaceuticals and to protect patients from unnecessary adverse effects, while avoiding unnecessary use of animals and other resources.

This guideline provides information for pharmaceuticals that are only intended to treat cancer in patients with late stage or advanced disease regardless of the route of administration, including both small molecule and biotechnology-derived pharmaceuticals. This guideline describes the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals and references other guidance as appropriate.