- DDMAC enforcement letters skyrocket. J. G. D. // Medical Marketing & Media;Nov2010, Vol. 45 Issue 11, p30
The article reports on the increasing number of letters sent by the U.S. Food and Drug Administration (FDA) that warn pharmaceutical marketers who violate agency advertising and promotion regulations.
- As I See It. Thacker, Paul D. // Medical Marketing & Media;Jan2012, Vol. 47 Issue 1, p26
The article presents the author's views on the move of the pharmaceutical industry to pressure the U.S. Congress and the Food and Drug Administration (FDA) regarding the conflict-of-interest on safety rules.
- So Little Time - So Much To Do. Auerbach, Michael // Pharmaceutical Processing;Jan2009, Vol. 24 Issue 1, p6
The article discusses the report published within this issue by John Avellanet on the business, regulatory and manufacturing issues that the U.S. Food and Drug Administration (FDA) will consider for the pharmaceutical industry in 2009.
- Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution. Kux, Leslie // Federal Register (National Archives & Records Service, Office of;10/24/2011, Vol. 76 Issue 205, p65730
The article presents a notice from the U.S. Food and Drug Administration (FDA) on the proposed requirement governing the registration of drug manufacturers and the listing of drugs in commercial distribution.
- FDA, Industry Hit Impasse on Waivers. // BioWorld Today;3/21/2011, Vol. 22 Issue 54, p6
This article reports on the impasse reached between the U.S. Food and Drug Administration (FDA) and the drug industry on how affiliates should be handled in determining user fee waivers for small businesses.
- FDA's Transparency Efforts. // BioWorld Today;10/20/2011, Vol. 22 Issue 204, p5
The article explores the failure of transparency efforts of the U.S. Food and Drug Administration regarding the performance goals and drugs developed by the pharmaceutical companies.
- WEEK IN WASHINGTON. // BioWorld Insight;5/30/2011, Vol. 19 Issue 22, p6
The article offers news briefs related to the pharmaceutical industry in the U.S. which include the introduction of the Qualifying Therapeutic Discovery Project Tax Credit Extension Act by U.S. Representatives Susan Davis, and Allyson Schwartz, and the establishment of a case for more disclosure...
- WEEK IN WASHINGTON. // BioWorld Insight;4/5/2010, Vol. 18 Issue 14, p5
The article offers news briefs related to pharmaceutical industry in the U.S. including the invalidation of the federal district court judge on Myriad Genetics Inc.'s patent claims on BRCA1 and 2 genes and the issuance of the Food and Drug Administration's (FDA) final guidance on dosage.
- Retrospection and Introspection at FDA. Hoffman, Michelle // BioPharm International;Sep2011, Vol. 24 Issue 9, p8
An introduction is presented in which the editor discusses a report from the U.S. Food and Drug Administration (FDA) on quality-by-design (QbD) initiative in the pharmaceutical industry.