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- Rx Distribution Licenses: A Matter of State
- U.S. FDA IDs Solutions to Drug Shortages
- Save Money by Attending TRI Courses
- Lack of Compendia Harmony for Visible Particles Causing Confusion
- Audit Program Part of FDA Pathway for Global Product Safety
- Progress of the Quality Topics at the ICH Meeting in Seville
- New Participation Opportunity: Nominate a BoD Candidate
- First PCMO TR Coming in March
- Interview with James Akers On Revised USP <1116>
- U.S. FDA Paves the Way for Biosimilars in US
Authors Wanted
The PDA Letter is PDA's membership publication covering the science, technology, quality, regulatory affairs and association news and updates relevant to the PDA community. It publishes 10 times per year, with issues in January, February, March, April, May, June, September and October, as well as two larger issues for July/August and November/December.
The PDA Letter is divided into seven sections, one for each PDA department and a features section. Feature articles are supplied by PDA members, industry and regulatory experts and occasionally by PDA staff. The PDA Letter Editorial Committee (PLEC) provides editorial oversight for all feature articles.
The PDA Letter is another forum for members to communicate their thoughts and expertise. PDA accepts submissions at any time for the Science and Technology and Quality and Regulatory Affairs sections of the Letter. Original articles relevant to the PDA Community will be considered for publication; these should be no more than 1500 words. Such articles can be case-studies (science/technology), reviews (of science, technology, regulations, books, etc.), commentary or summaries of PDA meetings, events, training, interest group/task force meetings, etc. All submissions should be sent to the PDA Letter Managing Editor.Write "PDA Letter Submission" in the subject line.
Feature articles (2000+ words) must be relevant to the PDA Letter Editorial Themes . Such articles can be case studies, reviews or commentary. Appropriate references should be included when applicable. Supporting graphics and photos should be high-resolution for print. Authors of feature articles should include a publishable (e.g., high resolution) photo and a brief biography. All submissions should be sent to the PDA Letter Managing Editor. Write "PDA Letter Submission" in the subject line.
PDA is looking for authors for the following topics in 2012:
|
Issue
|
Theme
|
Submit By
|
|---|---|---|
| January |
1) Combination Products |
November 3, 2011 |
| February |
1) Analytical Tools Initiative |
December 2, 2011 |
| March |
Manufacturing Innovation: Achieving Excellence in Sterile and Emerging Biopharmaceutical Technology |
January 20, 2012 |
| April |
Quality and Manufacturing Legislation |
February 3, 2012 |
| May |
Biofilm and Bioburden Management |
March 2, 2012 |
| June |
Rapid Screening Methods: Review of Screening Methods and Regulatory Perspectives |
April 2, 2012 |
| July/August |
Sterile Processing |
May 14, 2012 |
| September |
FDA Organizational Changes |
July 2, 2012 |
| October |
1) Biosimilars; Generics |
August 3, 2012 |
| November/December |
Reports from the PDA/FDA Joint Regulatory Conference |
September 10, 2012 |
While original writing is preferred, PDA will consider reprinting articles (consult with the PDA Letter Managing Editor)