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Compliance Regulations and Guidance Affecting your Industry
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.Categories
Compliance Trainings
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How FDA trains its investigators to review CAPA and what should you do to prepare
By - Jeff Kasoff
On Demand Access Anytime
By - Jeff Kasoff
On Demand Access Anytime
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
By - David Nettleton
Live September 10, 2024
By - David Nettleton
Live September 10, 2024
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Water System Investigation "How-To's" and Example Case Studies
By - T.C Soli
On Demand Access Anytime
By - T.C Soli
On Demand Access Anytime
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Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations
By - Jim Polarine
On Demand Access Anytime
By - Jim Polarine
On Demand Access Anytime
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How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
By - Charity Ogunsanya
On Demand Access Anytime
By - Charity Ogunsanya
On Demand Access Anytime
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Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
By - Joy McElroy
On Demand Access Anytime
By - Joy McElroy
On Demand Access Anytime
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Amended Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emerge ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for peramivir injection 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for intravenous (IV) administration in certain adult and pediatric patients issued on October 23, 2009, under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). FDA received inquiries related to the recommended dosing for patients with renal impairment. On November 19, 2009, FDA amended the Authorization letter and reissued the Authorization letter in its entirety to provide additional clarification. The Authorization letter, as amended and reissued, which includes explanations for its reissuance, is reprinted in this notice.
DATES: The amended Authorization is effective as of November 19, 2009.
Agency Information Collection Activities; Submission for Office of Management and Budget Review ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 26, 2010.
Agency Information Collection Activities; Submission for Office of Management and Budget Review ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Fax written comments on the collection of information by May 20, 2010.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adoption of the ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA’s collection of information from local, State, and tribal governmental agencies concerning their adoption of, or plans to adopt, all or portions of the FDA Food Code or its equivalent by regulation, law, or ordinance.
DATES: Submit written or electronic comments on the collection of information by June 14, 2010.
Determination of Regulatory Review Period for Purposes of Patent Extension; SAVELLA
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) has determined the regulatory review period for SAVELLA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Guidance for Industry Providing Regulatory Submissions in Electronic Format – Drug Establishmen ....
- Industry: All FDA Regulated Industry
This guidance represents 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.
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Produc ....
- Industry: All FDA Regulated Industry
This guidance represents 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. An alternative approach may be used if such 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.
Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematop ....
- Industry: All FDA Regulated Industry
This guidance represents 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 appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance
Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematop ....
- Industry: All FDA Regulated Industry
This guidance represents 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 appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application
- Industry: All FDA Regulated Industry
This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations (§ 11.1). The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 11) are referred to in this guidance document as predicate rules
Guidance for Industry Providing Regulatory Submissions in Electronic Format – Drug Establishmen ....
- Industry: All FDA Regulated Industry
This is one in a series of guidance documents intended to assist persons making regulatory submissions to FDA in electronic format. This guidance is designed to assist manufacturers with electronic submissions of drug establishment registration and drug listing information. The guidance and accompanying technical documents explain (among other things): • The statutory requirement to submit electronically drug establishment registration and drug listing information; • How to create a Structured Product Labeling (SPL)2 file for submitting drug establishment registration and drug listing information to FDA through the Electronic Submissions Gateway (ESG) using defined code sets and codes, i.e., a language recognized by the computer system; and • Beginning June 1, 2009, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted. FDA intends to update these documents regularly to reflect the evolving technology and user experience.
Revision of Organization and Conforming Changes to Regulations
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organizational changes in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency’s regulations
Effective Date:This rule is effective April 1,2009.
Guidance for Industry on Investigator Responsibilities—Protecting the Rights, Safety, and Welfa ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Investigator Responsibilities— Protecting the Rights, Safety, and Welfare of Study Subjects.’’ This guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The guidance also clarifies FDA’s expectations concerning the investigator’s responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties
Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfar ....
- Industry: All FDA Regulated Industry
This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). The goal of this guidance is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. This guidance is intended to clarify for investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights, safety, and welfare of study subjects.
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