Julia Post

Julia Post

Julia Post‘s practice consists primarily of representing clients in Hatch-Waxman patent litigation and providing advice to clients on a variety of federal and state regulatory matters relating to drugs and devices.

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FDA Holds Public Hearing and Seeks Comment on Draft Guidances Concerning Regulation of HCT/Ps

Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps).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 areas for further discussion … Continue Reading

Recent Reports Claim Improvements in FDA’s Review of Medical Device Submissions

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 investigational … Continue Reading

FDA Issues Draft Guidance on Combination Product Manufacturing

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current good manufacturing practice (cGMP) requirements for combination products, FDA has announced the availability of draft guidance that explains the final rule and further clarifies how manufacturers can comply with cGMP requirements.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, industry … Continue Reading

Regulation of Combination Products: A Hybrid Approach to CGMP and Postmarketing Safety Reporting Requirements

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 combination products. Under the rule, … Continue Reading

FDA Proposes New Pre-Decisional IDE Program

Yesterday, we discussed a new draft guidance issued by FDA concerning IDE decisions.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 device … Continue Reading

FDA Issues Draft Guidance on IDE Decisions and New Pre-Decisional IDE Program

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: approval, … Continue Reading

Use of New Administrative Order Authority to Up-Classify Devices: Proposed Order on “Sunlamp Products” Offers Glimpse Into FDA’s Approach

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 products,” including … Continue Reading

FDA Plans to Complete Classifications of Preamendment Devices by the End of 2014

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 reclassification orders.  With the … Continue Reading

Summary of 2012 FDA Promotional Enforcement Activity

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 … Continue Reading

OIG Finds Hospital’s Free Electronic Interface Arrangement Does Not Violate Anti-Kickback Statute

On December 12, 2012, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-20, which concluded that the proposed arrangement—wherein a hospital would provide free access to an electronic interface to community physicians for certain services—would not violate the federal anti-kickback statute (or “the statute”). The anti-kickback statute ascribes criminal liability to parties who … Continue Reading

Fungal Meningitis Outbreak: FDA Targets Promotional Claims in a Public Health Crisis

Earlier this month, FDA’s Center for Devices and Radiological Health (“CDRH”) issued a warning letter to The Avalon Effect, Inc. (“Avalon”), regarding the company’s Quantum Series Personal Wellness Pack (“Wellness Pack”).  Even more notable than the November 5, 2012 warning letter is what accompanied it: a press release announcing FDA’s issuance of the warning letter … Continue Reading