By Jennifer D. Newberger – With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content …
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Hyman Phelps McNamara
- UDI: When the Rule is Not EnoughJuly 29th, 2016
- “ACE” Is Here. Are You Ready? How FDA Intends to HelpJuly 27th, 2016
By Dara K. Levy – The Automated Commercial Environment (ACE), which went into effect for FDA-regulated products on June 15, 2016 (after several delays), is an electronic system operated by Customs and intended to automate import processing and expedite reviews for electronic import filings. It replaces …
- Striking the Right Balance – Comprehensive Addiction and Recovery Act of 2016July 26th, 2016
By John A. Gilbert Jr. & Alan M. Kirschenbaum – On Friday, July 22, 2016, President Obama signed into law the Comprehensive Addiction and Recovery Act (“CARA” or “Act”) of 2016, which is intended to help reverse the serious prescription drug abuse trend in the United …
- The Third Time’s the Charm for RAVICTI and Orphan Drug Designation: Another “Greater Safety” Clinical Superiority PrecedentJuly 25th, 2016
By Kurt R. Karst – We recently posted on an orphan drug clinical superiority precedent we came across: PURIXAN (mercaptopurine) Oral Suspension, 20 mg/mL, for the treatment of Acute Lymphoblastic Leukemia in pediatric patients. It’s the sixth “greater safety” orphan drug clincial superiority precedent we know …
- Two New Draft Guidances Outline FDA’s Proposed Approach to Regulatory Oversight of Next Generation Sequencing Diagnostic TestsJuly 24th, 2016
By McKenzie E. Cato* and Jeff N. Gibbs – As we reported previously (see previous post here), FDA has issued two long-awaited draft guidances on next generation sequencing (NGS) diagnostic tests. The first, “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro …
- FTC Announces Settlement with Herbalife; Consent Decree Sets Parameters for a Legal Multilevel Marketing BusinessJuly 20th, 2016
By Riëtte van Laack – Last week, FTC announced a settlement agreement with Herbalife International of America Inc., Herbalife International, Inc. and Herbalife Ltd. (Herbalife) under which Herbalife is to pay 200 million dollars and restructure its business (see FTC press release here). In the Complaint …
- FDA Releases “Notice” Advising of a Change in Inspections of Pharmacies Compounding Drug Products within FDCA Section 503A: Let’s Watch What Happens Next….July 20th, 2016
By Karla L. Palmer – FDA posted a “Notice” on July 12, 2016, advising compounding pharmacies regulated under Section 503A that, effective August 1, 2016, FDA is changing inspection procedures for Section 503A pharmacies (see Notice here). FDA announced that it now will make a “preliminary assessment” whether compounders …
- GMO Labeling Bill Is A Pen Stroke Away From Becoming Law: What Comes Next?July 19th, 2016
By Riette van Laack and Ricardo Carvajal – On Thursday July 14, the House approved legislation authorizing USDA to establish and administer a National Bioengineered Food Disclosure Standard. The bill, S.764, was previously approved by the Senate. The bill had been promoted as an urgent and necessary compromise by …
- FDA’s Mutual Reliance Initiative – Saving FDA Some Money at the Expense of Inspectional Quality?July 18th, 2016
By Mark I. Schwartz – The Mutual Reliance Initiative was announced by FDA a couple of years back. It has as its goal “…to increase…[FDA’s]…exchange, with the European Commission and the European Medicines Agency, of information that is critical to making decisions that protect our public …
- CMS Issues Release to Manufacturers Regarding Value-Based Purchasing ArrangementsJuly 18th, 2016
by Alan Kirschenbaum and Michelle Butler On July 14, 2016, CMS issued a release to manufacturers regarding value-based purchasing (VBP) arrangements. The purpose of the release is to (1) inform manufacturers how to seek guidance from CMS regarding the impact such arrangements might have on the …
- FDA Publishes Draft Guidance on What is “Essentially” a Copy of a Commercially Available Drug Under FDCA Sections 503A and 503B: Outsourcing FacilitiesJuly 15th, 2016
By Karla L. Palmer FDA published for comment two non-binding draft guidance documents addressing compounding of commercially available drug products by traditional pharmacies under FDCA Section 503A and outsourcing facilities under Section 503B. [Section 503A Draft Guidance is HERE, blogged separately] and Section 503B Guidance is …
- The Seventh Circuit Rejects First Amendment Protection for Commercial Speech Related to an Unapproved ProductJuly 14th, 2016
By David C. Gibbons & Jeffrey N. Wasserstein – The United States Court of Appeals for the Seventh Circuit recently issued an unpublished Opinion in United States v. LeBeau, No. 16-1289, 2016 WL 3619838 (7th Cir. July 5, 2016), a case in which the pro se …
- FDA Publishes Draft Guidance on What is “Essentially” a Copy of a Commercially Available Drug Under FDCA Sections 503A and 503B: Section 503A CompoundersJuly 14th, 2016
By Karla L. Palmer – On July 11, 2016, FDA published for comment two draft guidance documents addressing compounding of commercially available drug products by traditional pharmacies under FDCA Section 503A and outsourcing facilities under Section 503B (the Section 503A Draft Guidance is available here …
- Chemistry Amendment Saves Sun From Forfeiting 180-Day Exclusivity Eligibility for Generic GLEEVECJuly 13th, 2016
By Kurt R. Karst – It’s been a while since we posted on a 180-day exclusivity forfeiture issue, though we suspect that we’ll be doing it more in the coming months with some interesting issues on the horizon. But for now, FDA Blog Readers will have …
- FDA Proposes Additional Scientific Data to Support the Safety and Effectiveness of Certain Active Ingredients for Use in Topical Consumer Antiseptic RubsJuly 12th, 2016
By Riette Van Laack – On June 30, as required under the consent decree in the action by the National Resource Defense Council against FDA (see our previous post here), FDA published the amended tentative final monograph for consumer antiseptic rubs, also referred to as consumer rubs, leave …