Washington Information Source Co.

Washington Information Source Co. Providing FDA, EU regulatory news, analysis and documents since 1991. Washington Information Source Co. was founded in 1991 to provide specialized information, including news and federal documents, to subscribers in the health care industries.

Order regulatory documents, compliance manuals, research DVDs at www.FDADocuments.org

Operating as usual

The coronavirus has finally forced Washington officials to try to get more of our drug and device production on shore du...
03/21/2020
Trump’s 2017 call to ‘Make American Drug-Device Manufacturing...

The coronavirus has finally forced Washington officials to try to get more of our drug and device production on shore due to shortages caused by the Chinese. But as a publisher of FDA newsletters for nearly 30 years, I have long known about the U.S. overreliance on China, India and their substandard quality standards and submitted a letter to the Wall Street Journal on the subject (click below to read it) and praising President Trump for pushing drug companies to bring their manufacturing to U.S. shores again. That photo is a former Johnson & Johnson facility in North Brunswick, NJ, which is now a massive shopping mall. A number of U.S. drug and device facilities moved offshore the last 20 years.http://thebullelephant.com/trumps-2017-call-to-make-american-drug-device-manufacturing-great-again/

The shuttered Johnson & Johnson International Export Division in North Brunswick NJ. The property is now a big shopping mall.

You are looking at 3 journalists (me on the left) who have covered the FDA the longest among the Washington trade press....
05/05/2017

You are looking at 3 journalists (me on the left) who have covered the FDA the longest among the Washington trade press. Jill Wechsler, with Pharmaceutical Executive, who has been with them since 1990, and Bill Paulson, IPQ Publications, who started with the Gold Sheet in the early 1980s. I began covering FDA in 1986 for the Washington Drug Letter and Devices & Diagnostics Letter and started Washington Information Source in 1991. Perhaps the "Dean" of the FDA trade press now is Jim Dickinson of FDA Web View. He started with the Green Sheet in the mid 70s and launched his newsletters in 1982, but he was not at the meeting today. Photo taken at today's Food & Drug Law Institute annual meeting in Washington

03/16/2017

The proposed Trump FDA budget calls for a doubling of user fees, meaning, the agency would not be funded much from general tax revenue. This is not allowed under the current user fee law, which is up for renewal in September. So, it seems the president would have to get congressional and drug, device, biologics and food industry concurrence to do this. In addition, there would be criticism about potential pressure on FDA in compliance and enforcement if industry is paying the bills for that. Read about it in this week's GMP/Supply Chain Report. For a free copy, email us at [email protected]

March 31 deadline approaching.  Order this valuable manual and save 25%
02/27/2017

March 31 deadline approaching. Order this valuable manual and save 25%

NEW! GMP Validation Handbook. Every FDA and EMA guidance document on process validation, cleaning validation, computer validation - -and more! 25% discount if you order before March 31. Click here to learn more; http://www.fdadocuments.org/gmp-validation-handbook-new-for-2017/

Medical device CEO writes about how former acting Attorney General Sally Yates, fired by President Trump for disobeying ...
02/20/2017
Sally Yates’s Legacy of Injustice at the Department of Justice

Medical device CEO writes about how former acting Attorney General Sally Yates, fired by President Trump for disobeying an order, is no hero to him. He describes how the DoJ "Yates Memo" ensnared his firm in litigation. From the Wall Street Journal. WIS makes no comments either way on the article. https://www.wsj.com/articles/sally-yatess-legacy-of-injustice-at-the-department-of-justice-1487290306

Howard Root writes that in 2015 Sally Yates signed a memo that makes a potential criminal of every CEO. Time to tear it up.

Attended a public input session on the implementation schedule for the Drug Supply Chain & Security Act at FDA headquart...
10/14/2016
New photo by Ken Reid

Attended a public input session on the implementation schedule for the Drug Supply Chain & Security Act at FDA headquarters in Silver Spring today Read more about serialization, track and trace and verification in the next GMP/Supply Chain Report, to be emailed Oct. 27. visit www.FDAINFO.com for details

United Airlines gave PDA members and the media (me) a tour of a pharmaceutical cold chain storage facility, and belly ca...
10/05/2016
7 new photos by Ken Reid

United Airlines gave PDA members and the media (me) a tour of a pharmaceutical cold chain storage facility, and belly cargo bay of a 777 plane at Dulles International Airport in DC, which has seen a huge increase in the number of drug and device products coming in and out of the airport in recent years. Read more about this in next Thursday's GMP-Supply Chain Report

Washington Information Source Co.
07/28/2016

Washington Information Source Co.

BrExit's negative impact on drug, device regulation -- We also wrote about this in this week's GMP/SupplyChain Report. V...
06/24/2016
Brexit spells upheaval for EU and UK drug regulation

BrExit's negative impact on drug, device regulation -- We also wrote about this in this week's GMP/SupplyChain Report. Visit www.FDADocuments.org for details or email us to get a sample issue -- [email protected] http://www.reuters.com/article/us-britain-eu-corporates-pharmaceuticals-idUSKCN0ZA26J

Britain's vote to leave the European Union spells regulatory uncertainty for drug companies, with the London-based European Medicines Agency (EMA), which approves treatments for all EU countries, expected to have to relocate.

THis week marks the 30th anniversary of our editor, Ken Reid, starting his beat covering the FDA (Medical devices).  Ple...
06/22/2016
www.fdainfo.com

THis week marks the 30th anniversary of our editor, Ken Reid, starting his beat covering the FDA (Medical devices). Please visit our web site to examine our newsletters and get great insight on FDA regulation of drugs,devices and biologics www.FDAINFO.com

Order the new 2015 edition of The Pharmaceutical Supply Chain Compliance Manual.  It includes a DVD containing several i...
03/24/2015
Pharmaceutical Supply Chain Compliance Manual NEW! NEW!

Order the new 2015 edition of The Pharmaceutical Supply Chain Compliance Manual. It includes a DVD containing several important documents to help maintain the integrity of your drug products and ingredients. Includes a free trial subscription to GMP/Supply Chain Report. Order before May 15 and save $100 on each order. click here: http://www.fdadocuments.org/pharmaceutical-supply-chain-compliance-manual-new-new/

supply chain, counterfeiting, RFID, drug samples

We are offering a special $999 price for a new subscription to INSPECTION MONITOR, and are throwing in (for free) a DVD ...
02/27/2015
Inspection Monitor -- Unlimited PDF Edition

We are offering a special $999 price for a new subscription to INSPECTION MONITOR, and are throwing in (for free) a DVD of 483s and EIRs for pharmaceutical inspections. Subscribe to the PDF edition of I.M. and get our FULL collection of 483s and EIRs for all product categories . That collection sells for $899 regularly, but is yours FREE when you subscribe to Inspection Monitor in PDF. visit this web site for details http://www.fdadocuments.org/inspection-monitor-unlimited-pdf-edition/

GMPs, GMP inspections, pre-approval inspections, FDA compliance

New in 2015!  GMP/Supply Chain Report, a brand new biweekly information service that follows pharmaceutical supply chain...
01/04/2015
FDAinfo.com

New in 2015! GMP/Supply Chain Report, a brand new biweekly information service that follows pharmaceutical supply chain issues-- such as track and trace, counterfeiting, import/export matters and the new Drug Quality & Safety Act. Only $919 if you subscribe before the end of this month. AND , get a free Pharmaceutical Supply Chain Compliance Manual (which alone costs $549 plus shipping). Click here to learn more: http://www.fdainfo.com/index.php?id=vt

One-Stop Source or the Latest FDA News and Critical Industry Information

Since 1999, we have been publishing a weekly "online page" on FDA compliance and enforcement.  We call it Validation Tim...
12/18/2014
VALIDATION TIMES online

Since 1999, we have been publishing a weekly "online page" on FDA compliance and enforcement. We call it Validation Times Online. The page has taken various formats through the years. Today, we published our final weekly OL page. VT will change names and focus in January to GMP/Supply Chain Report. It will be a bi-weekly PDF newsletter devoted to supply chain compliance, counterfeiting, imports/exports and GMPs. http://www.fdainfo.com/VTPages/VTO121814.html

Federal law enforcement officials Dec. 17 arrested 14 owners and employees of New England Compounding Center (NECC) for charges including second-degree murder, racketeering, criminal contempt and mail fraud, in connection with the deadly 2012 fungal meningitis outbreak, according to news reports.

Get the COMPLETE VALIDATION MANUAL ON HTTP:www.fdadocuments.org  click on
02/13/2014
FDADocuments.Org -- FDA compliance documents, books

Get the COMPLETE VALIDATION MANUAL ON HTTP:www.fdadocuments.org click on

FDADocuments.Org -- FDA, EMA compliance documnents, manuals, research CDs; supply chain; software validation; GMPs; FDA inspections; Quality Systems

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08/24/2012

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