ComplianceOnline

Regulations & Guidances

Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.
Loading....

Final Guidance on Bioanalytical Method Validation - June 2018

  • Industry: Drugs and Chemicals (Pharma)

 On May 22, 2018, the US Food and Drug Administration (FDA) published a final guidance for industry entitled "Bioanalytical Method Validation.” This guidance incorporates public comments to the revised draft guidance that was issued in September 2013, and reflects advances in science and technology related to validating bioanalytical methods. 

FDA Guidance on cGMP Requirements for Combination Products

  • Industry: Drugs and Chemicals (Pharma)

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FDA Biosimilars Draft Guidance - Quality Considerations in Demonstrating Biosimilarity to Refer ....

  • Industry: Drugs and Chemicals (Pharma)

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.

FDA Biosimilars Draft Guidance - Scientific Considerations in Demonstrating Biosimilarity to a ....

  • Industry: Drugs and Chemicals (Pharma)

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.

FDA Guidance Clinical Studies Section of Labeling for Human Prescription Drug and Biological Pr ....

  • Industry: Drugs and Chemicals (Pharma)

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.

FDA Guidance Adverse Reactions Section of Labeling for Human Prescription Drug and Biological P ....

  • Industry: Drugs and Chemicals (Pharma)

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

FDA Guidance on Warning and Precautions Labeling for Drugs and Biological Products

  • Industry: Drugs and Chemicals (Pharma)

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.

Validation of Cleaning Processes

  • Industry: Drugs and Chemicals (Pharma)

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.

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Pro ....

  • Industry: Biotechnology

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. The agency is amending the current good manufacturing practice (CGMP) and quality system (QS) regulations that apply to HCT/Ps regulated as drugs, medical devices, and/or biological products to clarify the role of the new donor-eligibility regulations in relation to existing CGMP regulations. By preventing the transmission of communicable disease by the wide spectrum of HCT/Ps that are marketed now or may be marketed in the future, the agency’s action will improve protection of the public health and increase public confidence in new technologies.

Effective Date: This rule is effective May 25, 2005

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Pro ....

  • Industry: Biotechnology

The Food and Drug Administration (FDA) is correcting a final rule that published in the Federal Register of May 25, 2004 (69 FR 29786). The final rule required human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. The document was published with an error in the codified section. This document corrects that error.

Effective Date: This rule is effective March 24, 2006

Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and ....

  • Industry: Biotechnology

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is taking this action to complete the rulemaking initiated with the interim final rule

Effective Date: This rule is effective June 19,2007

Blood Vessels Recovered With Organs - Amendment to FDA and HRSA Regulations

  • Industry: Biotechnology

The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are amending their regulations to include as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, or cellular or tissue-based products (HCT/ Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the burden resulting from an organ procurement organization’s efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction).


Effective Date: This rule is effective April 11, 2007

Bioanalytical Method Validation - Guidance

  • Industry: Biotechnology

This guidance represents the Food and Drug Administration'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. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations

Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays

  • Industry: Biotechnology

The Food and Drug Administration (FDA) is implementing a direct final rule correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays which FDA was aware of were type 1 and type 2 and, therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA’s usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this directfinal rule

Effective Date:This rule is effective December 7, 2009

Revision of the Requirements for Publication of License Revocation; Confirmation of Effective D ....

  • Industry: Biotechnology

The Food and Drug Administration (FDA) is confirming the effective date of September 17, 2009, for the direct final rule that appeared in the Federal Register of May 5, 2009 (74 FR 20583). The direct final rule amends the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license. The rule provides that FDA will publish a notice in the Federal Register following revocation of a biologics license under FDA regulations and will include a statement of the specific grounds for the revocation. This document confirms the effective date of the direct final rule

Effective Date:This rule is effective September 17, 2009

Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable reco ....

  • Industry: Biotechnology

The Food and Drug Administration (FDA or the agency) is announcing the availability of a guidance for industry #187 entitled ‘‘Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs.’’ This guidance is intended to clarify FDA’s requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. The guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE animals, including FDA’s intent to exercise enforcement discretion regarding requirements for certain GE animals

Best Sellers
You Recently Viewed
    Loading