List of important us fda medical device regulations and guidance documents. Fdas guidance documents do not establish legally enforceable rights or responsibilities. This guidance document represents the food and drug administrations current thinking on this topic. How to implement good documentation practices pharmout. Requirements for good documentation practice gdp learn all about the good documentation practice including basics, gmp document preparation, issuance and retrieval of records, recording of time, correction of entries, handling of missing entries, blank space and cancellation of gmp records. The nature of the guidance and limits on its proscriptive. Good documentation practice commonly abbreviated gdp, recommended to abbreviate as gdocp to distinguish from good distribution practice also abbreviated gdp is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. Good documentation practices gdps in pharmaceutical. Draft guidance for industry on good reprint practices for. We also can help you prepare a 510k and register your devices with the fda. Drugsguidancecomplianceregulatoryinformationguidancesucm070072. Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. Fda has also issued guidance documents to describe some of the circumstances when it would not consider a manufacturers distribution of reprints, clinical practice guidelines, or reference texts regarding unapproved uses of approved drugs to be evidence of intended use andor false or misleading. Overall reaction positive always good to have clarity in a gray area 2.
In august 2015, the european union eu banned the marketing of about 700 indianmade generic drugs for alleged manipulation of clinical trials data. Ensuring data integrity in the fdaregulated laboratory with aiq and csv demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful audit or inspection for any good pharmaceutical practices gxpregulated laboratory. This draft guidance document represents the food and drug administrations current thinking on this topic. Fda publishes guidance for good manufacturing practices. The case for enhancing liability for offlabel drug. This white paper describes the fundamental requirements of good documentation practice gdp routinely used within the pharmaceutical industry as best practice standards or as a direct requirement of the code of good manufacturing practice gmp. Analysis of us food and drug administration warning letters.
Draft guidance for industry on good reprint practices for the distribution of medical journal ailicles and medical or scientific reference. Good reprint practices distribution of medical journal articles for. Guidance for industry good reprint practices for the distribution of medical journal. Fda guidance documents kidney disease drug development. The answer to the second question is a bit more complicated. This document expressed a desire that companies build. How far can medical device firms deviate from fdas. Fda issues enforcement discretion guidance and requests. Guidance discusses good reprint practices but stops short of labeling these as a safe harbor from prosecution for marketing an unapproved or misbranded product b.
Compliance with the food and drug administrations glp, or good laboratory practices, regulations 21 cfr part 58, as well as gmp regulations for drugs and medical devices 21 cfr part s 211 and 820 requires the use of good documentation practices. Fdas draft guidance on social media and offlabel communications. The department urges fda either not to promulgate a guidance for industry concerning good reprint practices, leaving the language of the food, drug and cosmetic act to speak for itself, or impose meaningful restrictions on the nature and validity of the articles that manufacturers may disseminate without fear of running afoul of legal limits. Health canada 2015 good manufacturing practices guidance document. Since the fda uses adobe acrobat 8, they have the ability to view pdf versions 1. Good reprint practices for the distribution of medical journal. Scientific or medical information that is distributed should. Good guidance practices ggps are fdas policies and procedures for developing, issuing, and using.
Good reprint practices of the distribution of medical journal. The information on this page is current as of april 1 2019 for the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Apic is concerned, however, that the fda guidance document relies on industry to voluntarily. Some fda guidance documents on this list are indicated as open for comment. Guidelines and best practices, continued 2 fda rule id sdtm variable maximum length in characters. Although you can comment on any guidance at any time see 21 cfr 10. Department of health and human services food and drug administration docket no. This revises the fdas 2009 draft guidance document on the subject, which was titled. Gdps are enforced by regulatory agencies such as the fda, tga, emea, health canada or who.
Good reprint practices, the document lists conditions under which sales rep resentatives may distribute reprints of journal articles describing drug. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Review of proposed fda guidance on offlabel use publications on february 15, 2008, a yearandahalf after the sunset of the statute1 intended to permit the dissemination of medical literature about unapproved uses of drugs and medical devices, the food and drug administration fda proposed a draft guideline for such dissemination. Good guidance practices and agenda fdas good guidance practices regulation pdf. Search for fda guidance documents distributing scientific and medical publications on unapproved new uses recommended practices revised guidance february 2014 download the draft. Fdas good reprint practices guidance pharma marketing. Fda finalizes guidance on distribution of reprints clarifies how manufacturers can hand out journal articles to docs. Fda issues draft guidance pertaining to good reprint. Today, the food and drug administration fda issued a guidance document communicating its. Good reprint practices draft guidance february 2008 on good reprint practices fda recognized public health value of distributing truthful. Guidance for industry good reprint practices for the. The table below lists all official fda guidance documents and other regulatory guidance.
Distributing scientific and medical publications on unapproved new uses recommended practices revised guidance march. Weve done the work for you by scouring their site to download, format, bookmark, and index them into a searchable acrobat file. Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical. Fda regulations affecting each stage phases of product development 3 fda regulations code of federal regulations, title 21 part 11 electronic records and signatures part 58 good laboratory practices nonclinical part 50 protection of human subjects. Fda has thousands of guidances and locating the ones specific for medical device clinical research insnt easy.
Procedural guidance for industry good reprint practices for the distribution of medical journal articles and medical or scientific reference. Fda is revising its 2009 guidance on good reprint practices to clarify the. How far can medical device firms deviate from fdas cleared. Guidelines and best practices christina chang, parexel international, taipei, taiwan. Pdf 89kb 52009 good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on.
Fda should clarify the impact of following the proposed guidance a. Food and drug administration fda made available for comment draft guidance titled good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices the draft reprint guidance. Eodrealexeuropean commission 2011 good manufacturing practices for medicinal products for human and veterinary use. Accordingly, the new draft guidance adds two sections that detail specific recommendations governing these types of documents. An executives guide to the fdas quality by design march 2008. As it did in the 2009 good reprint practices guidance and in prior law, fda does acknowledge in the new reprint guidance that the public health may benefit when health care professionals receive truthful and nonmisleading scientific or medical publications on unapproved new uses, and that fda recognizes the value to health care. The updated draft guidance serves to illustrate how manufacturers should avoid creating false or misleading or otherwise violative information, even under the guise of professional education. The following are some of the fda guidance documents that may be of interest. In the federal register of february 20, 2008, fda announced the availability of a draft guidance for industry entitled good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. Implementation of a publication strategy in the context of. Fda guidance on systemic lupus erythematosus drug development pdf. The fda has published a document that provides guidance to the industry concerning good manufacturing practices for cosmetics and is intended to assist in identifying the standards and issues that can affect the quality of products. Fda regulations code of federal guidance documents. Fda expands and clarifies its good reprint practices guidance march 2, 2014.
As a result, last friday, fda issued a new draft guidance revising the 2009 document to expand fdas guidance on good reprint practices to apply to medical reference texts and cpgs. Fda s good reprint practices guidance pros and cons of the proposed rules for distribution of offlabel information by john mack medical journals may soon become the pharmaceutical industrys newest physician marketing partner. Pharmacokinetics in patients with impaired renal function pdf version. The information on this page is current as of april 1 2019. Guidance for industry good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices.
Maintaining data integrity avoiding regulator scrutiny in the medical products industry. Fda news release communicated by asn regarding updated fda guidance pdf versionfda guidance on lupus nephritis pdf version was withdrawn and is being revised see here. Laboratory best practices for meeting regulatory and. Guidance documents issued by the fda office of the commissioner and covering topics affecting multiple regulated products and administrative processes. Fda updates reprint guidance, reiterates narrowness of off. That being said, they do not support all of these versions.
Fdas guidance documents, including this draft guidance, do not establish legally. Good reprint practices for the distribution of medical. Food and drug administration fda is seeking public comments on recently issued draft guidance titled, good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices draft reprint guidance. Good reprint practices of medical journal articles. Distributing scientific and medical publications on. On friday, february 15, 2008 on the eve of the threeday presidents day. Fda expands and clarifies its good reprint practices guidance.
See fda, good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. Instead, guidances describe the agencys current thinking on a topic and should be viewed only as. Us guidances fda guidances for medical device clinical. On january 12, 2009, the food and drug administration fda published a guidance document, good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices the good reprint practices guidance. Good guidance practices ggps are fdas policies and procedures for developing, issuing, and using guidance documents. As many of you know, the fda issues ectd guidance and specifications to clarify implementation of regulations. This guidance is intended to describe the food and drug administration s fda or agency current thinking regarding good reprint practices with regard to the distribution by a drug or medical.
Fdas good reprint practices guidance pros and cons of the proposed rules for distribution of offlabel information medical journals may soon become the pharmaceutical industrys newest physician marketing partner. Fda finalizes guidance on distribution of reprints. Implementation of a publication strategy in the context of reporting biases. While the fda does not regulate a physicians decision to prescribe fdaapproved drugs for offlabel uses, its recent guidance for industry on good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. From plis online program current issues in fda regulation. The guidance is a revision of a 2009 draft guidance, good reprint practices for the distribution of medical journal articles and medical or. Fda started to develop the concepts for good reprint practices in 1997 in response to fdama.
The working group, under the leadership of the office of policy in the office of the commissioner, prepared a report, entitled the food and drug administration report on good guidance practices. Who 2016 guidance on good data and record management practices, world health organization, switzerland, pp. Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses. Federal register guidance for industry on good reprint. Fda issues guidance document regarding good reprint. Fda issues enforcement discretion guidance and requests public comments on use of healthy in food labeling september 27, 2016. Fda issues draft guidance pertaining to good reprint practices for offlabel uses guidance will replace the safe harbor that was provided under the fda modernization act. The agency notes, however, that this draft guidance is not intended to affect the existing good reprint practice guidance for manufacturerinitiated distribution of medical journal articles that include offlabel uses, which limits the dissemination of scientific literature. You can search for documents using key words, and you can narrow or filter your results by product, date issued, fda organizational unit, type of document, subject, draft or final status, and comment period.