How we’ll remember 2013′s medtech innovations in 2023

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How we’ll remember 2013′s medtech innovations in 2023

December 30, 2013 9:28 am by | 0 Comments

In the medical devices industry, 2013 has been a year of major transition. That shift from volume to value is finally starting to gain momentum and meaning. The word “innovation”…


Zogenix prevails in initial challenge to Massachusetts emergency order banning ZOHYDRO ER

Zogenix prevails in initial challenge to Massachusetts emergency order banning ZOHYDRO ER

April 17, 2014 12:59 am by | 0 Comments

 By Kurt R. Karst –   When we first heard about the Complaint and Motion for Preliminary Injunction Zogenix, Inc. filed against Massachusetts Governor Deval Patrick, among others, alleging that…


FDA begins implementation of the Drug Supply Chain Security Act

FDA begins implementation of the Drug Supply Chain Security Act

April 2, 2014 11:24 pm by | 0 Comments

By William T. Koustas – FDA has begun its efforts to implement the Drug Supply Chain Security Act (“DSCSA”), also known as Title II of the Drug Quality and Security…



25 drug companies to phase out animal antibiotics

25 drug companies to phase out animal antibiotics

March 26, 2014 3:54 pm by | 0 Comments

WASHINGTON (AP) — The Food and Drug Administration says 25 pharmaceutical companies are voluntarily phasing out the use of antibiotics for growth promotion in animals processed for meat. Citing a…


Game On! Here’s an FDA-related crossword puzzle

Game On! Here’s an FDA-related crossword puzzle

March 26, 2014 12:00 pm by | 0 Comments

Earlier this week we gave a “Coming Soon” announcement about a forthcoming posting of an FDA-related crossword puzzle written by Jeffrey N. Gibbs and Etan J. Yeshua as part of a…


Limitations imposed on use of FDA warning letters

Limitations imposed on use of FDA warning letters

March 25, 2014 10:41 pm by | 0 Comments

By Anne K. Walsh – The Supreme Court of Arkansas recently overturned (here and here) a lower court’s $1.2 billion award to the State of Arkansas, and also reversed and…


Perrigo sues FDA over failure to grant therapeutic equivalence rating for testosterone gel

Perrigo sues FDA over failure to grant therapeutic equivalence rating for testosterone gel

March 23, 2014 10:23 pm by | 0 Comments

By Kurt R. Karst –        In a Complaint filed last Friday in the U.S. District Court for the District of Columbia, Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company (collectively “Perrigo”)…


Medical device recalls nearly doubled in 10 years

Medical device recalls nearly doubled in 10 years

March 21, 2014 9:39 am by | 0 Comments

The Wall Street Journal says a report to be released today will spotlight the increasing number of problems. The Wall Street Journal: Medical Device Recalls Nearly Doubled In A Decade…



FDA issues revised final guidance regarding administrative procedures for CLIA categorization

FDA issues revised final guidance regarding administrative procedures for CLIA categorization

March 19, 2014 10:01 pm by | 0 Comments

By Allyson B. Mullen – On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”).  FDA, Guidance for Industry…


State marijuana initiatives put U.S. in the hot seat with INCB

State marijuana initiatives put U.S. in the hot seat with INCB

March 18, 2014 12:32 pm by | 1 Comments

By John A. Gilbert – The 57th session of the Commission on Narcotic Drugs (“CND”) recently convened in Vienna, Austria.  A prominent issue on the first day of the general…


Court rules FTC’s substantiation requirements are applicable to claims for medical foods

Court rules FTC’s substantiation requirements are applicable to claims for medical foods

March 12, 2014 10:11 pm by | 0 Comments

By Riëtte van Laack – Defendants Wellness Support Network, and co-owners Robert and Robyn Held, marketed two diabetes products – Diabetic Pack and Insulin Resistance – as medical foods.  In…


FDA issues final guidance on the medical device pre-submission program

FDA issues final guidance on the medical device pre-submission program

March 4, 2014 11:30 pm by | 0 Comments

By Allyson B. Mullen – On February 18, 2014, the FDA issued the Final Guidance “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and…


Amarin Sues FDA after agency denies 5-Year exclusivity for VASCEPA

Amarin Sues FDA after agency denies 5-Year exclusivity for VASCEPA

February 27, 2014 10:19 pm by | 0 Comments

By Kurt R. Karst –   It’s “Exclusivity Week”!  First there was FDA’s Draft Guidance that, if finalized, would reinterpret the 5-year New Chemical Entity (“NCE”) exclusivity provisions of the…


Is patient safety at risk with new proposed digital health bill?

Is patient safety at risk with new proposed digital health bill?

February 26, 2014 11:00 am by | 2 Comments

Controversial legislation to reduce the regulatory burden for health-tech entrepreneurs has been introduced in the Senate this month. The Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014 was…


FDA denies 3 petitions seeking NCE exclusivity for combo drugs

FDA denies 3 petitions seeking NCE exclusivity for combo drugs

February 24, 2014 2:34 am by | 0 Comments

By Kurt R. Karst –       In moves that may displease both brand-name and generic drug manufacturers, and that could lead to litigation from both sides, FDA has with one hand…


FDA adding more inspectors in India to monitor pharmaceutical industry

FDA adding more inspectors in India to monitor pharmaceutical industry

February 21, 2014 2:53 pm by | 0 Comments

WASHINGTON (AP) — The head of the Food and Drug Administration says her agency will add more inspectors in India to better monitor drugs from the country’s burgeoning pharmaceutical industry,…