January 2015 | |||||
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice. In this Issue | |||||
Industry Insights | |||||
PHARMACEUTICALS Is it the Hard Knock Life for the Orphan Drug Industry or Will the Sun Come Out Tomorrow? Many of us remember the comic strip-turned Broadway musical turned-movie-turned movie, about little orphan Annie. My 8-year old daughter, Kayla, reminds me every day as she sings (on key), “It’s The Hard Knock Life” and “Tomorrow.” The lyrics, “’stead of treats, we get tricked, ‘stead of kisses, we get kicked,” come to my mind when I read the Food and Drug Administration’s (FDA) “clarification policy” regarding orphan drug exclusivity, published in a Federal Register notice, dated December 23, 2014. While some in industry might have hoped that FDA could change its orphan drug policy in light of a recent court decision challenging the agency’s decision on a particular product, the agency said, in keeping with the holiday season, bah humbug. As will be discussed, FDA said the court decision was case-specific, and its policy remains the same. More > | |||||
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MEDICAL DEVICES FDA Announces Comment Opportunity on CDRH Documents The Food and Drug Administration (FDA) has announced the opening of a docket dedicated to receiving comments on guidance documents that the Center for Devices and Radiological Health (CDRH) intends to publish in fiscal year 2015, as well as for previously-issued guidances that may be in need of revision or withdrawal. While FDA welcomes comments on guidance documents at any time, to ensure consideration under this particular solicitation, comments should be received no later than March 10, 2015. The guidance documents up for review are grouped into categories described in the following legal insight. More > FDA Releases Draft Guidance on 510(k) Transfers On December 19 and 22, 2014, the Food and Drug Administration (FDA) released a draft guidance and a Federal Register notice, respectively, on the transfer of a medical device premarket notification application, commonly referred to as a 510(k). The draft provides guidance to industry on how to notify FDA when a 510(k) marketing clearance is transferred and the procedures to ensure accurate and up-to-date information is included in FDA’s databases. FDA is asking for comments on the draft guidance by March 23, 2015. More > | |||||
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Hart Scott Rodino Update On January 15, 2015, the Federal Trade Commission announced its annual revisions to the jurisdictional thresholds in the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”). These changes, which will become effective thirty days after their publication in the Federal Register, increase the dollar thresholds to prompt the HSR Act’s premerger reporting requirements. Under the HSR Act, parties involved in certain proposed transactions, including mergers, asset acquisitions and acquisitions of voting securities, must notify the FTC and the Antitrust Division of the Department of Justice if the size of the parties involved and the value of the transaction exceed a certain threshold, absent an exemption. These thresholds are revised annually based on the change in gross national product. More > | |||||
Industry Activities and Recognition | |||||
Alan Horowitz Publishes Article on Personal Resident Alarms: More Protection or More Risk? Alan C. Horowitz's article entitled "Personal Resident Alarms: More Protection or More Risk?” was published in the December 2014 edition of Long Term Living Magazine, detailing the potential risks with bed and chair alarms in nursing homes. More > Michael Burke Launches Irish Export Insights Blog Michael E. Burke launched a blog entitled "Irish Export Insights: Practical Guidance for Irish and Northern Irish Companies on Doing Business in the U.S." The purpose of this blog is to help Irish and Northern Irish companies understand and mitigate the potential operational risk of exporting or expanding to the U.S. More > | |||||
Upcoming Events | |||||
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