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Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

Yesterday the OIG posted a report entitled “FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs” in response to a Congressional request expressing concerns about the safety and quality of...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the...more

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

Update on Significant DOT, FAA and Other Federal Agencies’ Aviation-Related Regulatory Actions - April 2015

This edition of the Cozen O’Connor Aviation Regulatory Update includes an overview of the FAA’s new contract maintenance rules, DOT and FAA notices on flight prohibitions in conflict zones, the latest news on the integration...more

Generic Drug Manufacturers to be Investigated by HHS for Recent Price Hikes

On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more

Health Alert (Australia) - March 30, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 25 March 2015 - Smythe v Burgman (No 2) [2015] NSWSC 150 - The New South Wales Supreme Court has held...more

FDA Requests Comments on WHO Recommendation to Classify Two Common Industrial Solvents as Psychotropic Substances

On January 27, 2015, the Food and Drug Administration (“FDA”) requested comments on a recommendation by the World Health Organization (“WHO”) to classify two common industrial solvents – gamma-butyrolactone (“GBL”) and...more

Health Alert (Australia) - December 8, 2014

In This Issue: Judgments and Reports. Excerpt from Reports: Australia. Department of Social Services - 4 December 2014 - 2014 Aged Care Approvals Round (ACAR) results. Senator Mitch Fifield,...more

Health Alert (Australia) - November 10, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: Australia. Health Practitioner Regulation Agency (AHPRA) and the boards - - 7 November 2014 - Media release AHPRA and the...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

FDA Releases Unique Device Identification Final Rule, Draft Guidance

On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI)....more

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

2013 Enforcement Predictions

I always like to make predictions at the beginning of each year. My track record is plus and minus – sometimes on target, sometimes off-target. The biggest story in the last five years has been the rise of FCPA...more

Corporate and Financial Weekly Digest - December 21, 2012

In this issue: - Nallengara to Replace Cross as Corp. Fin. Chief - FINRA Rule Relating to Private Placements of Securities Effective December 3 - Additional Guidance on FINRA’s Suitability Rule - No-Action...more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

China Life Sciences and Health Industry Client Briefing – October 2012 (November 16, 2012)

In This Issue: - China Becoming Healthcare R&D Hub (China Daily 2012-10-09) – October 9, 2012 - Imported Drugs to Go on China's Electronic Monitoring Network (Xinhua News Agency 2012-10-08) – October 9, 2012...more

China Issues Human Genetic Resources Management Regulations

Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the...more

DOJ and SEC Issue Highly Anticipated FCPA Guidance

On November 14th, the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange Commission (“SEC”) published A Resource Guide to the U.S. Foreign Corrupt Practices Act, their long-awaited, highly anticipated...more

Chinese FDA Soliciting Public Comments on Rules for Re-Packaging of IVDs

The State Food and Drug Administration (“SFDA”) in China published a draft of the Tentative Measures for the Administration of the Registration of Re-Packaging In-Vitro Devices (IVDs) (“Draft Measures”) on November 2 for...more

OFAC Publishes New Iranian Transactions and Sanctions Regulations

Recently the U.S. Treasury Department Office of Foreign Assets Control (OFAC) issued new Iranian Transactions and Sanctions Regulations. Notably, the regulations formally address financing provisions for authorized sales to...more

Under the Dome: Inside the Maine State House 9.21.12

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. If you would like more specific information regarding an item in this newsletter or related to...more

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