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Hyman, Phelps & McNamara, P.C. Document Search Results (257) Show: results per page Sort by:  | FDA Sets GDUFA Fiscal Year 2013 Facility User Fee Rates; Fewer Facilities Result in Higher Rates
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 17, 2013, previously published on January 16, 2013 In a notice that will be published in the January 17th Federal Register, FDA announces the establishment of Fiscal Year 2013 (“FY2013”) user fee rates established pursuant to the Generic Drug User Fee Amendments of 2012 (“GDUFA”) for both Active Pharmaceutical Ingredient...
| | FDA Considering Alternative Approval Pathway
Alexander J. Varond; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 17, 2013, previously published on January 15, 2013 FDA announced earlier this week that it will hold a public hearing to obtain input on a potential new pathway to expedite the development of drugs and biological products for serious or life-threatening conditions that would address an unmet medical need. The new pathway would be used to approve...
| | Patient Power in Orphan Drugs
William T. Koustas, Frank J. Sasinowski; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 15, 2013, previously published on January 13, 2013 FDASIA/PDUFA V elevates the role of patients in developing orphan therapies. It mandates that FDA implement ways to bring patients' views into drug development and FDA’s regulatory review. This is appropriate as it is often these patients that push development of orphan drugs forward.
| | New FDA Draft Guidance “Abuse-Deterrent Opioids—Evaluation and Labeling” to Permit Abuse-Deterrent Labeling Claims
David B. Clissold; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 12, 2013, previously published on January 10, 2013 FDA has released a Draft Guidance for Industry, titled “Abuse-Deterrent Opioids—Evaluation and Labeling.” Since at least 2005, Congress has noted the need for FDA guidance governing the development and approval of abuse-deterrent drug products. See e.g., H.R. Rep. No. 109-102...
| | A Pre-MMA 180-Day Exclusivity Punt? What Gives?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 11, 2013, previously published on January 8, 2013 Although the number of cases involving 180-day exclusivity under the version of the FDC Act in effect before the December 8, 2003 enactment of the Medicare Modernization Act (“MMA”) is nearing an end, the pre-MMA statute, and the handling of it by FDA and the courts, never fails to...
| | When is 5-Year NCE Exclusivity Less Than 5 Years?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 11, 2013, previously published on January 9, 2013 Every once in a while we receive a series of similar questions from various quarters such that a critical mass has been reached justifying a blog post on the topic. This is one of those posts. And it has to do with the always hot - and particularly hot as of late - topic of 5-year New Chemical...
| | FDA Ramps Up Focus on Advertising of Restricted Devices to Consumers
Jeffrey K. Shapiro; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 9, 2013, previously published on January 7, 2013 FDA has enhanced authority over the sale, distribution and use of devices that the agency designates as “restricted.” 21 U.S.C. § 360j(e). FDA almost always designates Class III devices as “restricted devices” in premarket application (“PMA”) approval...
| | On FSMA’s Second Anniversary, FDA Releases Two Major Proposed Rules
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 8, 2013, previously published on January 6, 2013 FDA released two long-awaited proposed rules to implement key provisions of the Food Safety Modernization Act ("FSMA"): Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding...
| | FDA and Ranbaxy Prevail in Dispute Over Generic DIOVAN 180-Day Exclusivity; Court Grants Motions for Summary Judgment
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 7, 2013, previously published on January 2, 2013 Last week in a post-Christmas decision, Judge John D. Bates of the U.S. District Court for the District of Columbia granted both FDA’s and Intervenor-Defendant Ranbaxy Laboratories Limited’s (“Ranbaxy’s”) Motions for Summary Judgment and denied Mylan Laboratories...
| | CDRH Releases Three Final Guidance Documents
Jennifer D. Newberger; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 7, 2013, previously published on January 3, 2013 On December 31, 2012, CDRH released three final guidance documents, the drafts of which were issued in the summer and fall of 2012. The quick finalization of these guidance documents is likely due to their fairly uncontroversial nature, since they are more about process than substance. Each...
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