July 27, 2018, Covington Alert

On July 11, 2018, the U.S. Food and Drug Administration (FDA or the Agency) made available a suite of six scientific draft guidance documents on human gene therapy (GT) products.

March 15, 2018, Covington Alert

On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs.

November 21, 2017, Covington Alert

In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...

June 29, 2017, The American Journal of Bioethics, 17:7, 51-53

September 19, 2016, Inside Medical Devices

Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps). Our client alert, accessed here, summarizes each of the guidance documents, highlights significant areas of discussion during the public hearing, and provides insights on potential ...

October 27, 2015, Inside Medical Devices

Two recent reports cite gains made by the Center for Devices and Radiological Health (CDRH) in strengthening the clinical trial enterprise and shortening the review times for marketing applications for medical devices.  The reports suggest that CDRH’s review processes are becoming more efficient, and that on average applicants can expect shorter review times for ...

February 9, 2015, Inside Medical Devices

Two years after issuing a final rule on current good manufacturing practice (cGMP) requirements for combination products, FDA has announced the availability of draft guidance that explains the final rule and further clarifies how manufacturers can comply with cGMP requirements. As we noted in our write-up of the final rule, following the rule’s issuance, ...

August 21, 2013, Inside Medical Devices

Starting July 22, 2013, as part of their compliance with current good manufacturing practices (“CGMP”), pharmaceutical companies that manufacture combination products containing a device component became subject to device Quality System Regulations (“QSRs”). As we previously discussed, on January 22, 2013, FDA issued a final rule on CGMP requirements for ...

June 21, 2013, Inside Medical Devices

Yesterday, we discussed a new draft guidance issued by FDA concerning IDE decisions.  While that post focused on FDA’s IDE decision-making process and the regulatory implications of those decisions, this post addresses a new program within CDRH—the Pre-Decisional IDE program—that FDA proposed in the draft guidance. To further help applicants reach their goal of ...

June 21, 2013, Inside Medical Devices

On June 14, 2013, FDA issued a draft guidance, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” to clarify the regulatory implications of FDA’s IDE decisions and to propose a new program to facilitate trial designs in support of marketing approval or clearance. FDA may take three actions with respect to IDE applications: ...

May 22, 2013, Inside Medical Devices

On May 6, 2013, FDA issued a proposed order to reclassify ultraviolet (UV) lamps intended for tanning from class I devices (general controls) exempt from premarket notification to class II devices (special controls) subject to premarket notification.  FDA also proposed to change the focus of the classification regulation from “ultraviolet lamps” to “sunlamp ...

April 12, 2013, Inside Medical Devices

Last month, FDA announced that it plans to complete classification actions for remaining preamendments devices by the end of 2014.  These actions could take the form of orders requiring the filing of premarket approval applications (PMAs) or notices of completion of a product development protocol (PDPs) for various devices (referred to as “calls for PMAs”) or ...

March 28, 2013, Covington E-Alert

March 20, 2013, Inside Medical Devices

In 2012, the Office of Compliance at CDRH issued 15 warning letters relating to the promotion of approved or cleared medical devices, a significant increase from both 2011 and 2010.  CDRH’s letters cited a variety of promotional materials, including Twitter posts and billboards, but websites were by far the most prominently featured promotional piece in...… ...

March 18, 2013, Covington E-Alert

February 28, 2013, Inside Medical Devices

Will 2013 be the year FDA provides comprehensive guidance on the use of social media to promote regulated medical products?  It has been more than three years since FDA held a public hearing on the use of the Internet and social media tools to promote drugs and devices.  And for at least that long, FDA...… Continue Reading

February 27, 2013, Covington E-Alert

January 28, 2013, Covington E-Alert

December 28, 2012, Covington E-Alert

December 3, 2012, Covington E-Alert

October 31, 2012, Covington E-Alert

September 28, 2012, Covington E-Alert

August 31, 2012, Covington E-Alert

July 26, 2012, Covington E-Alert

June 11, 2012, Covington E-Alert

May 29, 2012, Covington E-Alert

April 30, 2012, Covington E-Alert

March 22, 2012, Covington E-Alert

February 29, 2012, Covington E-Alert