Compliance
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Volume 2 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SPC), package information and classification for the supply, readability of the label and package leaflet requirements. The Notice to Applicants below has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency ( EMA ) . This Notice has no legal force and does not necessarily represent the final views of the Commission.
Reference documents - EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use. | Public health , European Commission
Representatives of Wisconsin’s Technical Colleges will bring solutions to the skills gap at the Manufacturing Matters Conference May 9. Read more... Warm Spring Means Don’t Delay in Controlling Invasive Plants With the warm winter and the unseasonably warm spring, plants are emerging and growing several weeks earlier than usual, and this includes invasive plants that threaten to crowd out native species. Read more... The State of Wisconsin has a website to provide you with an official resource for influenza information.
sconsin.gov - Portal Home
The pharmaceutical manufacturing sector is part of the manufacturing sector (NAICS 31 - 33). It consists of establishments primarily engaged in one or more of the following: manufacturing biological and medical products; processing botanical drugs and herbs; isolating active medical principles from botanical drugs and herbs; manufacturing pharmaceutical products intended for internal and external consumption in such forms as tablets, capsules, ointments, powders and solutions.
Pharmaceutical Sector | Laws and Regulations | US EPA
EPA
Published in 1962, Carson's book, Silent Spring, sparked modern interest in environmental protection, culminating in the creation of EPA in 1970. More about Rachel Carson.
U S Food and Drug Administration Home Page
For cookouts, picnics, Little League and soccer games, Americans buy 80 percent the packaged ice sold in the U.S. between Memorial Day and Labor Day. FDA regulations keep packaged ice safe.
FDA Law Blog
By Jennifer D. Newberger - On Tuesday, April 17, 2012, Senators Burr and Coburn introduced the Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act, or the “PATIENTS’ FDA Act.” This bill is intended to complement the proposed user fee agreements negotiated between FDA and the drug and device industries by “requiring transparency in the review and decision progress against the initiatives and metrics agreed to in the prescription drug, generic drug, biosimilar, and medical device user fee agreements.”