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To Recap, Here's What Each Issue Provides :
- Insight into the implications of FDA and congressional actions related to drug safety;
- First word of FDA enforcement actions on issues ranging from off-label promotion to improper manufacturing practices; and
- Developments in the generics sector, DTC advertising and drug pricing, regulatory guidances on drug impurities, structured product labeling and IND applications
PLUS: in every issue, you get links to additional key documents that support WDL’s articles, such as FDA letters, guidances, warning letters and 483s, rules, full texts of proposed legislation, GAO reports and more. Other features include:
- Weekly Updates: Now get weekly updates and comprehensive coverage of warning letters issued by the FDA to drugmakers and coverage of court cases that affect drug companies, including a weekly round-up of FDA-related court actions directly to your computer.
- The Buzz: Find out who’s coming and going at the agencies, law firms and lobbyist organizations that are important to drugmakers.
- Who's Looking?: Get a listing of interesting FOIA requests to the FDA, and who they’re asking about.
- FDA Calendar: Receive calendar of highlights of upcoming meetings, conferences and comment deadlines.
- Profiles: Get profiles of FDA officials, reviewers, advisory panel members, lawmakers and others whose decisions affect drugmakers.
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