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Australia Therapeutic Goods Advertising Code 2007

  • Industry: Drugs and Chemicals (Pharma)

In Australia, advertisements for therapeutic goods that are directed at consumers should get approved before broadcasting or publication and must comply with Therapeutic Goods Advertising Code.

The latest version is Therapeutic Goods Advertising Code (TGAC) 2007 which took effect on March 8, 2007.
 

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.

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.

Uniform Compliance Date for Food Labeling Regulations

  • Industry: Packaging and Labeling

The Food and Drug Administration (FDA) is establishing January 1, 2014, as the uniform compliance date for food labeling regulations that are issued between January 1, 2011, and December 31, 2012. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 8, 2008, FDA established January 2, 2012, as the uniform compliance date for food labeling regulations issued between January 1, 2009, and December 31, 2010 (January 1, 2012 fell on a Sunday; therefore the uniform compliance date was January 2, 2012).

DATES: This rule is effective December 15, 2010. Submit either electronic or written comments by February 14, 2011. 

Fair Packaging and Labeling Act

  • Industry: Trade and Logistics Compliance

The Fair Packaging and Labeling Act (FPLA) of 1966 was enacted to ensure that customers are provided enough information to choose wisely among competing products. The Act is enforced by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products a ....

  • Industry: Packaging and Labeling

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.
 

Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Req ....

  • Industry: Packaging and Labeling

This document is intended to assist industry in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462, 120 Stat. 3469). The statute created a new section 502(x) in the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 352(x)). These requirements apply to manufacturers, packers, and distributors of nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application. In particular, this document covers the following topics: (1) the meaning of domestic address for purposes of the labeling requirements of section 502(x) of the Act, (2) FDA’s recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x) of the Act, and (3) FDA’s intent regarding enforcing the labeling requirements of section 502(x) of the Act

 


 

Guidance for Industry and Review Staff Labeling for Human Prescription Drug and Biological Prod ....

  • Industry: Packaging and Labeling

This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling. Although not specifically required, the pharmacologic class can also appear in other sections of labeling. This guidance only applies to the use of the pharmacologic class in the Indications and Usage section of Highlights

 

Guidance for Industry - Adverse Reactions Section of Labeling for Human Prescription Drug and B ....

  • Industry: Packaging and Labeling

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

 

Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage,and Transportatio ....

  • Industry: Packaging and Labeling

The Food and Drug Administration (FDA) is issuing a final rule that requires shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation, and requires these producers to maintain records concerning their compliance with the rule and to register with FDA. FDA is taking this action because SE is among the leading bacterial causes of foodborne illness in the United States, and shell eggs are a primary source of human SE infections. The final rule will reduce SE-associated illnesses and deaths by reducing the risk that shell eggs are contaminated with SE


Effective Date:This rule is effective September 8, 2009

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