Regulating Drugs: Development & Approval
Tip 1: Dig Deeper into Development & Approval
If your story is about drugs, it is essential to delve into their development and approval history. There’s a trove of valuable information. Although all countries have their own regulatory agency (see Appendix), the work by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) has great influence on the worldwide pharmaceutical market. Evidence submitted by the industry to regulatory agencies to prove product safety and efficacy may be public and available on regulators’ websites, even if it often doesn’t appear in post-approval marketing materials. The drug development and approval process consists of five so-called phases shown in the illustration below.
Despite government restrictions, journalists around the world are using freedom of information laws to understand the COVID-19 pandemic and the response of international, national, and local authorities. GIJN’s Toby McIntosh outlines how to craft an effective freedom of information request and provides tips and suggestions on where to make requests and important questions to ask.
Governments around the world, some which have sent workers home, are announcing interruptions in responding to freedom of information requests. Journalists are being told to expect delays in more than a dozen countries. But press freedom advocates warn that countries are taking big steps backward just when the free flow of information is most needed. GIJN’s Toby McIntosh rounds up some of the nations which have been affected.
What’s the global data journalism community tweeting about this week? Our NodeXL #ddj mapping from October 21 to 27 finds a panel of leading data visualization practitioners discussing the practice of visualization in an age of disinformation, Kloop exposing how Kyrgyzstani authorities privatized large swaths of a public park with no oversight, and The Guardian highlighting the minimal changes between former British prime minister Theresa May’s Brexit deal with current PM Boris Johnson’s new deal.
When the Bureau of Investigative Journalism asked to see a contract between property developers and the North London borough of Haringey, its reporters were disappointed to receive a heavily-redacted document. This was part of a drive by the UK nonprofit to test the Local Audit and Accountability Act 2014, which gives citizens and journalists the right to access the accounts and related documents of city councils and other local authorities.
Getting information from official or unofficial sources lies at the heart of investigative journalism. This section of the GIJN/NAJA guide covers:
How to make official requests for information
How to work with whistleblowers
How to protect yourself
Using Access Laws to Get Information
Information laws are key prying devices in the investigative toolkit. However, the unique legal status of Indigenous governmental bodies may result in unique challenges when pursuing open information requests with these entities. The freedom of information laws of the United States and Canada do not cover tribal nations and few tribes have adopted their own access laws. There are also nuances in national laws.
The legal system constantly produces information on the behavior of powerful people and entities. Based on his latest research, law expert Roy Shapira has unpacked for GIJN how investigative reporters can use the full potential of legal sources for better reporting.
What’s the global data journalism community tweeting about this week? Our NodeXL #ddj mapping from June 3 to 9 finds @sto3psl mapping places the Avengers visited in Europe, @fedfragapane visualizing which elements in the periodic table are in danger of running out, @srfdata highlighting the top worries of the Swiss and @propublica doing researchers and journalists a huge public service by making 3 million US nonprofit records text-searchable.
What’s the global data journalism community tweeting about this week? Our NodeXL #ddj mapping from March 25 to 31 finds @ajlabs visualizing air raids through sound, @infobae exposing secret dictatorship decrees in Argentina, @albertocairo presenting on how charts can be misleading and how to fix them, and @TheEconomist laying bare the “crimes” against data visualization they have committed.
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More than 115 countries worldwide have laws that require officials to turn over public records. Of course, even in the countries that have no laws it never hurts to ask. But there’s an advantage to using an access law — variously called freedom of information laws, access to information laws, right to information and right to know laws. COVID-19 Update:
Tips on Making FOIA Requests About COVID-19 A GIJN guide on using freedom of information (FOI) laws to understand the COVID-19 pandemic. Mountains of vital stories about the coronavirus are hidden in public records.