Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

Medical Device and Drugs Labeling and Advertising

1. Service Description

We provide customized labeling and advertising material for your products to be in compliance with both FDA and EU regulations ensuring that you do not make any false claims or being misbranded

Advertisements and promotional labeling material are required to be submitted under 21 CFR 314.81(b)(3)(i) or 601.12(f)(4) as part of the post-marketing reporting regulations for approved applications with either Forms FDA 2253 (CDER or CBER) or 2567.

There will be productivity increase and cost savings of more than 80% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.


2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 80 % > 80 % > 80 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.


3. Solution Approach

The FDA regulation differentiates labeling and advertising as per 21 CFR 202.1(l). Advertising means advertisements in publications or broadcast through audiovisual media, such as radio, television, and telephone communication systems.

In case of medical device we will ensure that labeling and advertising adheres to

  1. Intended Use
  2. Indications of Use

For drugs, the FDA holds that labeling encompasses any of the following kinds of written, printed, or graphic material:

  1. Material containing drug information
  2. Material disseminated by or on behalf of the manufacturer of that drug
  3. Material for use by healthcare professionals

We will ensure that following type of labeling is in compliance:

  1. Brochures, detail pieces, bulletins
  2. Literature reprints
  3. Films, videos, CD/DVD-ROM disks
  4. PowerPoint presentations
  5. Homemade sales aids
  6. Automated telemarketing
  7. Press releases

We will also ensure that requirements for advertising and promotional labeling listed below are met:

  1. Claims must be consistent with prescribing information.
  2. No false or misleading statements or omissions are permitted.
  3. Materials must fairly balance benefits and risks.
  4. Substantiation must be provided.
  5. Labeling must be accompanied by prescribing information
  6. Advertising must include brief summary content

The FDA generally does not pre-approve the advertising and promotional labeling but are submitted at the time of first use. Certain exceptions are launch materials, accelerated approval and FDA special requirement. FDA relies on after-the-use enforcement to address violations


4. Definitions

Label: The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. FDA Section 201(k)

Labeling: The term "labeling" means all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.  FDA Section 201(m)

Misbranding: If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.   FDA Section 201(n).


5. Applicable Laws, Regulations and Standards

  1. Federal Food, Drug, and Cosmetic Act – Section 201 - http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm
  2. Advertising/Labeling Definitions  - http://www.fda.gov/CDER/handbook/adverdef.htm