By Kurt R. Karst – Every once in a while FDA gets asked a question along the lines of: “Can my company submit two ANDAs to FDA – from two different subsidiaries – each containing the same bioequivalence data?” . . . or “Can my company …
Menu
Hyman Phelps McNamara
- FDA’s Anti-Franchising Policy: What Is It and Where Did It Come From?March 4th, 2015
- The Brookings Institution Issues Report on National Medical Device Surveillance SystemMarch 2nd, 2015
By Allyson B. Mullen – In 2012, CDRH initiated an action plan to strengthen the medical device surveillance system (we previously reported on this plan here). As part of this initiative, a multi-stakeholder Planning Board was created with the purpose of “envisioning an MDS with the …
- FDA SOS Act Makes Reappearance as Concern Over Sequestration GrowsMarch 2nd, 2015
By Kurt R. Karst – Amidst concern that the 2013 sequester could make a repeat appearance and reduce both FDA’s budget from Congress and industry-financed user fees to the Agency, Representatives Anna Eshoo (D-CA) and Leonard Lance (R-NJ) have introduced legislation to exempt FDA user fees …
- No Leg to Stand On: Sandoz Takes on Amgen’s Bid for an Injunction in Filgrastim Biosimilar LitigationFebruary 27th, 2015
By Kurt R. Karst – There’s been a lot of activity in the budding biosimilars world this year, and it’s only February. On the FDA front, the Agency reportedly has 5 Section 351(k) biosimilars applications under review: (1) Sandoz’s version of Amgen’s NEUPOGEN (filgrastim); (2) Celltrion’s …
- District Court Rules that Maine Drug Importation Law is Unconstitutional and Preempted by the FDC ActFebruary 25th, 2015
By Kurt R. Karst – In a 19-page decision handed down earlier this week by Judge Nancy Torresen of the U.S. District Court for the District of Maine, the court ruled that Maine’s 2013 law, titled “An Act To Facilitate the Personal Importation of Prescription Drugs …
- A New Variation on an Old Theme: FDA Refuses PTE Regulatory Review Period Revision Based on Filing Refusal DecisionFebruary 24th, 2015
By Kurt R. Karst – It’s been a long time since we last posted on a Patent Term Extension (“PTE”) controversy – a little more than a year it seems (see here) – but that doesn’t mean we’re not keeping an eye on decisions coming out …
- FDA’s Global Food Safety Ambition: Might the Eye be Bigger Than the Stomach?February 24th, 2015
By Ricardo Carvajal – The question (in the title of this post) occurred to us in preparing for FDLI Food Week 2015, taking place as this is written. When FDA issued its Pathway to Global Product Safety and Quality in 2011, the agency set forth this ambitious objective: …
- As Snow Falls, We See a Flurry of Developments Related to FDA Efforts to Actively Regulate LDTsFebruary 22nd, 2015
By Jamie K. Wolszon – Amidst the winter storms that have struck the East Coast this January and February, there has been, and will continue to be, a flurry of developments related to FDA efforts to actively regulate Laboratory-Developed Tests (LDTs). Those developments include a White …
- How Orphan Drugs Came to Be Called “Orphan”February 22nd, 2015
By Frank J. Sasinowski & Andrew J. Hull* – Even though we often blog on orphan drug developments (see two of our most recent posts here and here), many may be unaware of the origin of the term “orphan.” Today, we may think that the term …
- FDA Officially Releases Four Compounding Draft Guidance Documents and Its Draft Memorandum of Understanding; Part Two: FDA Provides Details on the Draft Standard MOUFebruary 20th, 2015
By Karla L. Palmer – Following our blogpost describing the four human drug compounding draft guidance documents and draft Memorandum of Understanding (MOU) that FDA released last Friday, FDA formally published the documents in the Federal Register on February 19th. Interested persons should note the docket …
- Would You Balk at Disclosing Confidential Information to Your Competitors?February 18th, 2015
By Kurt R. Karst – Without even knowing what we’re talking about, it’s probably safe to say that any company would immediately answer “Yes!” to the question posed in the title to this post. But that’s exactly what FDA is asking some ANDA applicants to do …
- Can the AIA’s New IPR and PGR Post-Grant Proceedings Trigger a Forfeiture of 180-Day Exclusivity Under the Failure-to-Market Provisions?February 17th, 2015
By Kurt R. Karst – Last year we posted on the possible effect of Inter Partes Review (“IPR”) on the forfeiture of 180-day exclusivity eligibility under the so-called failure-to-market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I) added by the 2003 Medicare Modernization Act. With no decision …
- Another Holiday Surprise: FDA Releases Four Draft Guidances and a Draft Memorandum of Understanding Related to Drug CompoundingFebruary 17th, 2015
By Karla L. Palmer – As it did on the eve of another holiday weekend last July (see our previous posts here and here), on this past Friday (the 13th), FDA released the long-awaited draft Memorandum of Understanding (MOU) addressing interstate shipment of compounded preparations under …
- The 2014 Numbers Are In: FDA’s Orphan Drug Program Shatters RecordsFebruary 16th, 2015
By Kurt R. Karst – Earlier this month in a post concerning the Orange Book we mentioned our love of data and discussed how solid figures can reveal some interesting conclusions. After all, it’s rather difficult – and dangerous – to come to a conclusion without …
- This Just In: NIH Extends the Comment Period for its Proposed Rule on Clinical Trials Registration and Results ReportingFebruary 15th, 2015
By James E. Valentine* & Anne Marie Murphy – The National Institutes of Health (“NIH”) just extended the comment period for its Notice of Proposed Rulemaking on clinical trial registration and results submission (“NPRM”) until March 23, 2015. As we previously reported, the NPRM proposes to …