RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

RAPS Regulatory Focus Features

AUTHOR GUIDELINES and STYLE GUIDE 


Download the Guidelines PDF                                                                                                                                                              Last updated 9 September 2020


About Regulatory Focus

Regulatory Focus (RF) is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS). It provides in-depth feature articles for those involved with the regulation of healthcare and related products, including pharmaceuticals, medical devices, biologics, biotechnology, in vitro diagnostic devices, nutritional products, cosmetics, veterinary products, and related fields.

RF provides ongoing access to timely information addressing real-world issues in the regulatory environment. It is the only source of timely, quality regulatory news, information, and analysis fully dedicated to covering regulatory issues associated with healthcare products and the regulatory profession.

The publication is delivered digitally on the RAPS website (www.raps.org).


Areas of interest to our readers

  • Advertising, promotion, and labeling
  • Biologics and biosimilars
  • Business and economics (regulatory business acumen)
  • Ethics
  • Manufacturing
  • Medical devices
  • Pharmaceuticals
  • Policy (government, regulatory bodies, law and legislation)
  • Quality and compliance
  • Regulatory profession (education and professional development)
  • Risk strategy and management
  • Science and research (regulatory science and leading-edge technology)

Articles are written by industry professionals and reviewed by a body of volunteer technical reviewers, including the RAPS Editorial Advisory Committee, consisting of experts in regulatory subject matter from around the world. About 10 feature articles are published each month, and there is a 12-month editorial calendar focusing on key topical areas and emerging issues.

RAPS members can benefit from in-depth examination and analysis of regulatory and related topics with monthly themes in addition to continuous access to feature articles, guest editorials, perspectives, opinion pieces, case studies, and research studies.

RF accepts unsolicited articles but does not guarantee publication of all submissions. It is preferred a prospective author first submit a two- to three-sentence synopsis of the fact-based, in-depth article topic specifying its relevance to the regulatory profession. This information can be emailed to Renée Matthews, Senior Editor, Regulatory Focus, at rmatthews@raps.org.

 

AUTHOR GUIDELINES (Also see Presubmission Author Checklist below)

Download the Guidelines PDF
 

Article presentation
Length
Articles should run to at least 2,000 words, including references but excluding tables. Most articles submitted range between 2,800 and 3,500 words (6-8 pages as per specs outlined under the Format heading below).


Format

  • 11 pt Calibri
  • Single-line spacing between sentences
  • Paragraphs set flush left (no para indent)
  • No extra spacing after paragraphs
  • Line between paragraphs
  • Avoid excessive formatting. Please do not use Headers, Footers, Endnotes, or Footnotes.
  • Please do not use automatic numbering or the automatic endnote/footnote tools in Word.
  • If any website links (URLs) are included, please confirm that they are correct.
  • Try to avoid links that require registration fees.
  • All articles should be written in a formal, non-conversational tone.
  • Use only one space after a period, question mark, or exclamation at the end of a sentence.


Elements

  • Headline – no more than 75 characters
  • Byline – e.g., By First Author, PhD, Second Author, MSc, and Third Author, MD
  • Brief summary/abstract of article – no more than 85 words
  • Introduction to article – provides background information and states goals of article
  • Subheads

                   ○ Level 1 subheads – bold typeface
                   ○ Level 2 subheads – bold, italic typeface

  • Bulleted points – not numbered (see below, under Punctuation, Bulleted lists)
  • Tables and Figures – in increasing numeric order (see below, under Tables and figures)
  • Text citations – superscripted numbers (e.g.,1) in increasing numerical order (see below, under References)
  • Conclusion summary
  • Abbreviations list – in alphabetical order, after text and before Reference section
  • References in increasing numerical order, corresponding to text citations (see below, under References)
  • Brief bio for each author


Biography
A biographic summary for each author, of no more than three or four sentences, should be submitted with the article. The summary should include current job title, years of experience in regulatory affairs, area of responsibility, graduate degrees, professional affiliations, and contact email.


Commercialism
Commercialism is strictly prohibited. Commercialism is deemed to be the inclusion of visual, written, or verbal references to any specific company and/or product for its promotion or commercial advantage. Articles promoting a specific product or company will not be accepted.


Correctness and accuracy
Authors are responsible for the correctness and accuracy of all statements contained in the article (the publisher assumes no liability). Accepted articles become the property of the publisher and may not be published elsewhere without the written permission of both the author and publisher.


Figures and tables
Only figures and tables meeting the following criteria will be accepted:

  • 300 dpi (high-resolution suitable for printing at actual size or larger).
    Line art, usually tagged as .gif and low-resolution photographs, tagged as .jpg (.jpeg) downloaded from websites are not acceptable.
  • PC format. Images must be in .bmp, .psd, .tif, .pdf, .eps, .ai (Illustrator only) [Adobe InDesign does not read Illustrator .eps files], submitted via email. Please compress artwork using .zip software. Files in .txt cannot be used.
  • MAC format. Images must be in .tif, .pdf, .psd, .eps, high-resolution .jpeg, .ai (Illustrator only).
  • We cannot accept digital figures created in CAD, Visio, or other drafting programs.
  • We cannot accept figures only as embedded graphics in a Word or multipage PowerPoint document. They must be submitted in the formats noted above. PowerPoint figures submitted with one page per file are acceptable.
  • Tables and figures are referenced in the text by Arabic numbers, in increasing consecutive order, e.g., Table 1, Table 2; and Figure 1, Figure 2.
  • Tables must not be submitted as images.
  • Each table must have a heading. The table column/row header should explain clearly and concisely the components of the table.
  • Identify any previously published material by giving the original source in the form of a reference at the end of the table caption.
  • Figure and table captions must be included with the figures and tables. All necessary symbols, notations and axes must be of sufficient size to be legible when reduced for publication.
  • If abbreviations are used in the table or figure, list the abbreviation and with term written out in full at the end of the table/figure, in alphabetical order.
  • Author must provide appropriate credit for figures and tables if from another source and must obtain the necessary permissions of figures that already have been published. Source should be included as a reference and the reference number placed at the end of the caption.
  • Only simple or text-heavy tables should be created in Word. If submitting the actual data to plot the figures or charts, the information must be provided in Excel.


Keywords Each article should include four to six keywords, in alphabetical order.


Ownership
Authors must sign a copyright release form transferring copyright ownership to RAPS before an article is published. (This does not apply to government employees.)


Payment RAPS does not pay any financial remuneration to authors.


Permissions
Authors wishing to include figures, tables or text passages that already have been published elsewhere are required to obtain permission from the copyright owner(s) and to include evidence that such permission has been granted when submitting their articles. Any material received without such evidence will be assumed to originate from the authors.


Recertification RACs earn five recertification points for each article published.


Reprints
After the article has been published, it may be posted on the author’s company website. Contact the editor for more information.


Technical and editorial review
All articles published in Regulatory Focus undergo double-blind peer review. Each article is reviewed by at least three reviewers from a pool of technical reviewers for timeliness, quality of presentation, relevance to audience, technical accuracy, and areas for improvement.

Reviewers evaluate submissions and provide feedback on the article, suggest improvements, and make a recommendation to the senior editor about whether to accept, reject, or request changes to the article. The ultimate decision rests with the senior editor, but reviewers play a significant role in determining the outcome.

After revisions and acceptance of the article, it will be edited for style, content, presentation of references, grammar, and punctuation in accordance with the RAPS Style Guide. The article is sent to the lead author for proofing and sign-off before it is published.

 

STYLE GUIDE

Abbreviations and acroynms
Abbreviations and acronyms should follow the full spelling of the term in parentheses after first reference.

Example 1, The US Food and Drug Administration (FDA) is looking into the matter. (Note capitalization.)
Example 2, … sponsors must submit a clinical trial application (CTA) for authorization. (Note use of lowercase.)

Note, if the abbreviation is for an established group or agency, then the first letter of each world words of its name are title capitalize when written out in full.

For each subsequent reference, use only the abbreviation. If the name is referenced only once, there is no need to include the abbreviation after that single reference.

Acronyms are abbreviations that can be pronounced as words, for example, AIDS, COVID, and NASA. RAPS style is to use uppercase for acronyms as well, although some publications use title case for acronyms of four letters or more, as with a proper noun.

Some common abbreviations that need not be spelled out at first mention would include COVID-19 and HIV-AIDS.

Degrees and credentials
Periods are not used in abbreviations for educational degrees or certifications, e.g., PhD, MBA, RAC. Note: avoid prefixes, including Dr.

The United States, United Kingdom, and the European Union
Abbreviate as US, UK, and EU, respectively, and use without periods. The abbreviations can be used both as nouns and as adjectives.


Capitalization
Commonly used words
Cabinet, Congress, Federal Register

Do not capitalize:
agency
congressional
mark, marked, marking in reference to the CE Mark
ministry
quality assurance
regulatory affairs
sponsor
treaty, act, regulation, federal (unless in title)


Clinical trial phases
Phases of clinical trials are identified using Arabic numerals and lowercase for “phase” – phase 1, phase 2, phase 3.


Contractions
Limit use of contractions, such as “don’t” and “isn’t,” except in direct quotations. Spell out “do not,” “is not,” etc.


Dates
Use the international style for dates for all RAPS documents, e.g., 16 February 1971.
Spell out the months ‒ do not use abbreviations unless space considerations make it absolutely necessary. Do not use numerical dates, e.g., 2/16/1971.


Degrees and certifications
Generally, include an individual’s credentials for doctorates (PhD), medical degrees (MD), doctor of pharmacy degrees (PharmD) and Regulatory Affairs Certification (RAC).

If referring to or quoting a lawyer, it is acceptable, but not mandatory, to indicate the JD. Do not include any degree lower than a master’s level.

Offset a person’s degree with a comma. Do not use periods in abbreviations of degrees and credentials, e.g., PhD, JD, MD. Do not use prefixes, including Dr.


Emphasis Do not use uppercase, boldface, or italics as a device to emphasize a point.


Gender-specific pronouns
Often sentences can be constructed so no gender-specific pronoun is necessary, e.g., “Regulatory professionals make important contributions to their employers’ organizational strategies…” instead of “… a regulatory professional makes an important contribution to his or her employer’s organizational strategy…”.

Use “his or her” or “he or she” only when absolutely necessary. Avoid using a construction such as “he/she.” When referring to an individual, never use “their.”


Medical devices
Classifications 
Medical device classes are identified using Roman numerals, and “Class” is capitalized, i.e., Class I, Class II, etc.


510(k) clearance
When referring to the US Food and Drug Administration’s clearance of medical devices through the 510(k) process, always use the term “clearance” or “cleared.” Do not use “approval” or “approved.”


Numbers
Cardinal (one, two, three, etc.) and ordinal numbers (first, second, third, etc.) from one to nine should be spelled out if they are not used with a unit, such as 3 miles, 6.2 kg.

Numbers 10 and higher should be written as numerals (10, 11, 12, etc.).


Punctuation
Bulleted lists
When creating a vertical bulleted list, RAPS adheres strictly to The Chicago Manual of Style. This reference states that no punctuation is to follow a bulleted list if the list contains words, phrases or sentence fragments.

Bulleted lists that are not complete sentences are not capitalized.

If the bulleted or numbered list contains complete sentences (subject and verb), capitalize the first letter and place a period after each item in the list.

Comma Use the serial comma.

Hyphen
Reference a dictionary or guidance on whether a word is used as one word; two separate words; or two words, hyphenated.

There are a few terms that are always written as one word in RAPS style even though they are used elsewhere as two words, e.g., healthcare, drugmaker, and lifecycle.

Note use of the hyphen in the following:

Asia-Pacific
benefit-risk
cosponsor
e-book, email
decision making
direct-to-consumer (adjectivally)
drugmaker
FDA-approved (drug, biologic, and PMA submissions)
FDA-cleared (510(k) submissions)
First-in-Man
healthcare
lifecycle
multicenter, multisite
nonbinding, nonclinical, noncommunicable
noninferiority
on-site (adjectivally), on site (all other instances)
over-the-counter (adjectivally)
pre-authorization
preapproval, preclinical, presubmission
postauthorization, postapproval,
postmarket, postsubmission
roundtable
shelf life
subsection
third-party (adjectivally), third party (as a noun)
timeframe

 

Quotation marks and punctuation

  • Periods (.) and commas (,) always go inside the quotation marks.
  • Semicolons (;) and colons (:) always go outside the quotation marks.
  • Question marks (?) and exclamation points (!) go inside the quotation marks if they are part of the quotation, outside if they are not.


References and text citations
In Reference lists, please do not use endnotes or footnotes; auto-numbering; or italics or quote marks for titles.

If there are multiple sources for a document, use the source most likely to remain unchanged, e.g., for an FDA guidance, use the agency website instead of linking to a copy of the document on a consulting firm’s website.

  • All statements of fact within the text sourced from an original document must be noted next to the corresponding text using a superscripted number and listed in the reference section, using the same number as the text citation.
  • The superscripted text citation numbers (e.g., 32,11-16) should be presented sequentially, in increasing numerical order.
  • The superscripted number should go after the punctuation, e.g., … risk strategy.45,56,59
  • The sources listed in the reference section should be presented sequentially, in increasing numerical order, reflecting the order in which the references are cited in the text.
  • If a reference is cited a second time, or multiple times, in the article, use the first number applied to the reference for each subsequent mention of the reference in the text. Do not use the Ibid/Op cit system.
  • References with URLs should include the date of publication or of last update (e.g., Last updated 7 April 2019. or Published 3 March 2020.), as well as the date on which the author last accessed the article through the URL (e.g., Accessed 14 July 2020.)
  • Where possible, use PubMed abbreviations for journal titles. The titles are not italicized and take a single period at the end of the full title, not after each abbreviated word in the title.
  • A reference entry for a source should generally include the following elements, in this order:

                   ○ Name of content originator, e.g., author or organization.
                   ○ Title of document, sentence case – no italics or quotation mark.
                   ○ Abbreviated journal name – single period at the end of the title, not italic.
                   ○ Year;Volume(Issue):page range
                   ○ Page range numbers are separated with a hyphen; don’t repeat duplicate numbers, e.g., pages 103 to page 109, would be 103-9;
                       pages 1175-1190, would be 1175-90.  
                   ○ URL, if applicable – hyperlinked to source.
                   ○ If a URL is used, include the date the item was published/posted/last updated or revised, e.g., Published 16 November 2019.
                       Last updated 16 November 2019.
                   ○ Also include the most recent date on which the article was accessed through the URL, e.g., Accessed 15 January 2020.


Style for specific references

Journal article, print journal
5. Sun J, Li S-H, Liu S-M et al. Improvement in cardiac function after bone marrow cell therapy is associated with an increase in myocardial inflammation. Am J Physiol Heart Circ Physiol. 2009;296(1):43-50.

Journal article, online
7. Zhou P, Zhou J. The primary cilium as a therapeutic target in ocular diseases. Front Pharmacol. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7333185/. Published online 26 June 2020. Accessed 17 June 2010.

For website URLs
26. National Medical Products Administration. NMPA issued the 2019 annual report for medical device registration. http://english.nmpa.gov.cn/2020-03/17/c_471589.htm. Last updated 17 March 2020. Accessed 17 July 2020.

For website URLs when the document is in a language other than English
37. [In French]. Le Ministère de l’Education Nationale et de la Jeunesse et des Sports. Rentrée 2020: Modalités pratiques [Back to school 2020: Practical guidelines]. https://www.education.gouv.fr/rentree-2020-modalites-pratiques-305467. Last updated 19 August 2020. Accessed 17 July 2020.

Presentation at a conference
37. Du X, Blank B, Chan B, et al. Orally available small molecule CD73 inhibitor reverses immunosuppression through blocking of adenosine production. Paper presented at: American Association for Cancer Research Virtual annual meeting; 27 April 2020. https://www.abstractsonline.com/pp8/#!/9045/presentation/10523. Accessed 30 July 2020.

Book (whole)
25. Venables WN. Modern applied statistics with S. 4th ed. New York, NY: Springer Publishing Co; 2003.

Book chapter
17. Solensky R. Drug allergy: Desensitization and treatment of reactions to antibiotics and aspirin. In Lockey P, ed. Allergens and Allergen Immunotherapy. 3rd ed. New York, NY: Marcel Dekker; 2004:585-606.

Package insert
11. Qinlock [package insert].  Waltham, MA: Deciphera Pharmaceuticals; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213973s000lbl.pdf. Accessed 21 July 2020.


PRESUBMISSION AUTHOR CHECKLIST

Before submitting your article, please ensure that the following requirements have been met:

□ Formatting

  • 11 pt Calibri
  • Single-line spacing between sentences
  • Paragraphs set flush left (no para indent)
  • Single line between paragraphs
  • No extra spacing after paragraphs
  • No Headers, Footers, Endnotes, or Footnotes
  • No pages with company/organization logos

□ Article is at least 2,000 words (including references, but excluding tables)
□ Headline – no longer than 75 characters
□ Byline – FirstName LastName, postgrad degrees
□ Brief summary, abstract of article – no longer than 85 words
□ Introduction to article includes topic background/context and purpose of article
□ Text citations – superscripted numbers in increasing numerical order
□ Tables – heading, notes, abbreviation list, source (if applicable)
□ Figures – heading, legend, abbreviation list, source (if applicable)
□ Level 1 subheads – bold typeface
□ Level 2 subheads – bold, italic typeface
□ Bulleted points – not numbered
□ Abbreviations list in alphabetical order – after text, before Reference section
□ References complete as per Author Guidelines
□ References – URLs must be accompanied by publish/update/revise and access dates
□ URLs – do they go to the correct source?
□ Brief bio for each author


Thank you
 



For more information, contact:
Renée Matthews, Senior Editor, Features, Regulatory Focus rmatthews@raps.org
Regulatory Affairs Professionals Society, 5635 Fishers Lane, Suite 400, Rockville, MD 20852