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Looking to 2019 and beyond - accessing the U.S. pharmabiotech market: U.S. drug inspections in China: Staying ahead of FDA enforcement trends
  • Hogan Lovells
  • USA, China
  • January 8 2019

China’s pharmaceutical manufacturing industry is amongst the largest, and, from a supply-chain perspective, one of the most important, in the world

2018 Highlights in Canadian Life Sciences IP
  • Smart & Biggar/Fetherstonhaugh
  • Canada
  • January 7 2019

In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: 1 a June update on biosimilars

What the Government Shutdown Means for Imports
  • Arent Fox LLP
  • USA
  • January 2 2019

The US Government has been under a partial shutdown since December 21, 2018, and it is anyone’s guess when the shutdown will end. Congress has

FDA Draft Guidance on Verification Systems Under the Drug Supply Chain Security Act for Prescription Drugs
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 29 2018

On October 24, 2018, FDA issued draft guidance on verification systems under the Drug Supply Chain Security Act (DSCSA) for prescription drugs. FDA

Congress Seeks to Strengthen Response to the Opioid Crisis Through the Support for Patients and Communities Act
  • Frost Brown Todd LLC
  • USA
  • October 29 2018

On October 3, 2018, Congress approved the SUPPORT for Patients and Communities Act (H.R. 6). This bipartisan legislation is now headed to President

VQIP application portal will open October 1st for the Fiscal Year 2020 benefit period
  • Keller and Heckman LLP
  • USA
  • September 24 2018

The Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP). VQIP is intended to expedite the review and

FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A
  • Hogan Lovells
  • USA
  • September 21 2018

Yesterday, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to

FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities
  • Knobbe Martens
  • USA, European Union
  • September 19 2018

On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that

Impending Tariffs on China to Impact Manufacturers of Dietary Supplements, OTC Drugs, Cosmetics
  • Morgan Lewis
  • USA, China
  • September 19 2018

Newly approved tariffs would impose 10 to eventual 25 tariffs on hundreds of chemical ingredients imported from China used for many FDA-regulated

FDA announces new export certification program
  • Keller and Heckman LLP
  • USA
  • September 4 2018

The U.S. Food and Drug Administration (FDA) recently announced a new export certification program, along with the fees that will be assessed, for