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Generalstreik!
Drosten for Kanzler!
SOFORT!
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Thalia-Chef Michael Busch will eins auf die Schnauze
TOTALBOYKOTT BEI THALIA!
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Manfred Doepp: im Fernsehen.
Seine Patienten: im Grab.
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Männer sind blöde.
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Geisteskranke Homöopathie-Anhänger sind eine ernste Gefahr für die Allgemeinheit
http://www.transgallaxys.com/~kanzlerzwo/index.php?topic=11953.0
*** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** ***
Das Innenministerium muß handeln:
Homöopathische 'Ärzte' als organisierte Kriminalität
Beweisstücke für die Staatsanwaltschaft
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Krieg! Krieg!

Homöopathen im Krieg!
Binnenkonsens ermordet!

Kriegsbericht von der Postfront:
Ab 6.2.2021 wird zurückstudiert!

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Was Einem die Vollidioten ohne Masken ins Gesicht pusten:



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Mindestens jeder siebente Pfaffe im Erzbistum Köln ist ein Täter



Vorsicht vor Pfaffen!

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Author Topic: FTC to Host September Workshop in Washington, DC, to Examine Advertising for OTC  (Read 2765 times)

ama

  • Jr. Member
  • *
  • Posts: 1145

https://www.ftc.gov/news-events/press-releases/2015/06/ftc-host-september-workshop-washington-dc-examine-advertising

[*QUOTE*]
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FTC to Host September Workshop in Washington, DC, to Examine Advertising for Over-the-Counter Homeopathic Products
For Release
June 1, 2015

Tags:

    Over-the-Counter Drugs and Devices
    Bureau of Consumer Protection
    Consumer Protection
    Advertising and Marketing
    Health Claims

The Federal Trade Commission will host a public workshop on Monday, September 21, 2015 in Washington, DC, to examine advertising for over-the-counter (OTC) homeopathic products.

During the last few decades, the homeopathic drug industry in the United States has grown considerably from a multimillion-dollar to a multibillion-dollar market. In that time, the homeopathic drug market has shifted from one based primarily on formulations prescribed for an individual user to mass-market formulations widely advertised and sold nationwide in major retail stores.

Because of rapid growth in the marketing and consumer use of homeopathic products, the FTC is hosting a workshop to evaluate the advertising for such products. The workshop will bring together a variety of stakeholders, including medical professionals, industry representatives, consumer advocates, and government regulators.

The FTC invites the public to submit research, recommendations for topics of discussion, and requests to participate as panelists. The workshop will cover topics including:

    A look at changes in the homeopathic market, its advertising, and what consumers know;
    The science behind homeopathy and its effectiveness;
    The effects of recent class actions against homeopathic product companies;
    The application of Section 5 of the FTC Act to advertising claims for homeopathic products; and
    Public policy concerns about the current regulation of homeopathic products.

Public comments can be submitted electronically. Paper submissions should be sent to: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue, NW, Suite CC-5610 (Annex B), Washington, DC  20580, or delivered to: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex B), Washington, DC 20024. Paper submissions should reference the Homeopathic Medicine & Advertising Workshop both in the text and on the envelope. The deadline for submitting public comments is Friday, November 20, 2015.

The FTC also has set up an email box for anyone interested in being a panelist at the event or suggesting additional topics for discussion. It is homeopathy@ftc.gov (link sends e-mail), and will be open until August 1, 2015.

The workshop is free and open to the public. It will be held at the Constitution Center, 400 7th St., SW, Washington, DC 20024. The Commission will publish a detailed agenda at a later date.

Reasonable accommodations for people with disabilities are available upon request. Requests should be submitted to Fawn Bouchard via email at Fbouchard@ftc.gov (link sends e-mail) or by calling 202-326-2743. Requests should be made in advance and include a detailed description of the accommodations needed and contact information.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook (link is external), follow us on Twitter (link is external), and subscribe to press releases for the latest FTC news and resources.
Contact Information

MEDIA CONTACT:
Mitchell J. Katz
Office of Public Affairs
202-326-2161

STAFF CONTACT:
Gregory W. Fortsch
Bureau of Consumer Protection
202-326-3617
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Julian

  • Boltbender
  • Jr. Member
  • *
  • Posts: 1495
Comments requested about draft homeopathy regulatory guidance
« Reply #1 on: November 13, 2019, 08:58:06 PM »

https://www.regulations.gov/document?D=FDA-2017-D-6580-4828

[*quote*]
Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry

This Notice document was issued by the Food and Drug Administration (FDA)

For related information, Open Docket Folder
Action

Notice of availability.
Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for FDA staff and industry entitled “Drug Products Labeled as Homeopathic.” The revised draft guidance, like the original version, describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval that potentially pose higher risk to public health. In response to comments received, we have revised the draft guidance and are reissuing it in draft form to enable the public to review and comment before it is finalized.
Dates

Submit either electronic or written comments on the draft guidance by January 23, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Addresses

You may submit comments on any guidance at any time as follows:
Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal:
https://www.regulations.gov

Follow the instructions for submitting comments.

Comments submitted electronically, including attachments, to
https://www.regulations.gov
will be posted to the docket unchanged.

Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process.

Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on
https://www.regulations.gov

If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

Mail/Hand delivery/Courier (for written/paper submissions):

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:

All submissions received must include the Docket No. FDA-2017-D-6580 for “Drug Products Labeled as Homeopathic.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at
https://www.regulations.gov
or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

Confidential Submissions

To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
https://www.regulations.gov
Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf

Docket:

For access to the docket to read background documents or the electronic and written/paper comments received, go to
https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
For Further Information Contact

Elaine Lippmann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796-3600; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

Supplementary Information

I. Background

In the Federal Register on December 20, 2017 (82 FR 60403), FDA announced the availability of a draft guidance for FDA staff and industry entitled “Drug Products Labeled as Homeopathic.” This draft guidance was intended to describe how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval that potentially pose higher risk to public health.

In response to comments received, we have revised the draft guidance and are reissuing it to enable the public to review and comment before it is finalized. In particular, we have added a definition of “homeopathic drug product” for purposes of the guidance, added additional explanation of some of the safety issues that contributed to the development of the draft guidance, and clarified the intent to use risk-based factors to prioritize enforcement and regulatory actions involving homeopathic products that are marketed without required FDA approval. In addition, the revised draft guidance removes the statement that the Agency will withdraw the compliance policy guide (CPG) simultaneous with the issuance of the final guidance. Elsewhere in this Federal Register, FDA is announcing the withdrawal of CPG 400.400.

This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The revised draft guidance, when finalized, will represent the current thinking of FDA on “Drug Products Labeled as Homeopathic.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

Persons with access to the internet may obtain the draft guidance at

either
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

or
https://www.regulations.gov

Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23335 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P
 
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« Last Edit: November 13, 2019, 09:10:07 PM by Julian »
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