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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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Proposed CMS Rule: Medicare, Medicaid, Children's Health Insurance Programs; Transparency Repor ....
- Industry: Drugs and Chemicals (Pharma)
The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.
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 - Medical Device Reporting for Manufacturers
- Industry: Medical Devices
This guidance document describes the new Medical Device Reporting requirements for manufacturers. It is intended for both domestic and foreign medical device manufacturers, and is based on the Medical Device Reporting (MDR) requirement published in the final rule dated December 11, 1995. The MDR regulation provides a mechanism for FDA to identify and monitor significant adverse events involving medical devices, so that problems may be detected and corrected in a timely manner.
FDA Guidance on Adverse Event Reporting to IRBs - Improving Human Subject Protection
- Industry: Clinical Research
The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects. Institutional Review Board (IRB) reviews and approves the clinical protocol, informed consent forms, study advertisements, and patient brochures.
FDA Draft Guidance on Risk Information in Prescription Drug & Medical Device Ads, Promotional L ....
- Industry: Drugs and Chemicals (Pharma)
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.
FDA Draft Guidance on Human Factors and Usability Engineering to Optimize Medical Device Design
- Industry: Medical Devices
In June 2011, the Food and Drug Administration issued draft guidance on using human factors and usability engineering to optimize medical device design. The aim of this guidance document is to help the medical device industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.
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.
Section 402 of the FDA Food Safety Modernization Act (FSMA), P.L. 111-353 - Whistleblower Provi ....
- Industry: All FDA Regulated Industry
The Food Safety Modernization Act (FSMA) of 2011 not only formulated regulations to protect consumers by ensuring safety in the manufacture and production of food, but also includes statutes to protect employees who turn whistleblowers.
FDA Draft Guidance for Device Industry and Staff for Postmarket Surveillance
- Industry: Medical Devices
On August 16, 2011, the FDA issued draft guidance for the medical device industry and its own staff on how to conduct postmarket surveillance. This new guidance, when it is finalized, is expected to supersede the guidelines issued in 2006.
FDA 2011 Draft Guidance on Financial Disclosure by Clinical Investigators
- Industry: Clinical Research
The FDA released draft guidance in May 2011 to assist clinical investigators, industry and FDA staff in interpreting and complying with regulations governing financial disclosures by clinical investigators, 21 CFR Part 54.
Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when M ....
- Industry: Medical Devices
FDA has developed this draft guidance document to provide greater clarity for FDA reviewers and industry regarding the factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices. FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.
FTC Guides Concerning Use of Testimonials in Advertising
- Industry: Banking and Financial Services
In October 2009 the Federal Trade Commission (FTC) released its final Guides Concerning the Use of Endorsements and Testimonials in Advertising. The Guides revise the FTC's initial guidelines published in 1980, providing advertisers and spokespeople with insight on how to keep their endorsement and testimonial advertisements in compliance with the FTC Act, particularly in light of new issues posed by the emergence of social media. The Guides took effect on December 1, 2009.
Compliance Policy Guide - Prescription Drug Marketing Act - Pedigree Requirements under 21 CFR ....
- Industry: Drugs and Chemicals (Pharma)
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.
Prescription Drug Marketing Act
- Industry: Drugs and Chemicals (Pharma)
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.
California e-Pedigree Law
- Industry: Drugs and Chemicals (Pharma)
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.
Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use
- Industry: All FDA Regulated Industry
This document address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. It also addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).
Bioequivalence Recommendations for Specific Products
- Industry: All FDA Regulated Industry
This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site,2 rather than having to request this information from the Agency and wait for the Agency to respond, as has been the case in the past. The FDA believes that making this information available on the Internet will streamline the guidance process, making it more efficient than the previous process. This process also will provide a meaningful opportunity for the public to consider and comment on BE study recommendations for specific drug products.
Bioequivalence Recommendations for Specific Products
- Industry: All FDA Regulated Industry
This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site, rather than having to request this information from the Agency and wait for the Agency to respond, as has been the case in the past. The FDA believes that making this information available on the Internet will streamline the guidance process, making it more efficient than the previous process. This process also will provide a meaningful opportunity for the public to consider and comment on BE study recommendations for specific drug products.
Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation S ....
- Industry: All FDA Regulated Industry
This guidance is intended to address two topics pertaining to Medication Guides for drug and biological products. This guidance applies when FDA intends to exercise enforcement discretion regarding when a Medication Guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient4 instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient. The guidance also clarified when a Medication Guide will be required as part of a risk evaluation and mitigation strategy (REMS).
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