• where experts go to learn about FDA
  • Uncategorized

    • CDRH Issues Final Guidances Regarding Use of Real-World Evidence and Procedures for Advisory Committee MeetingsSeptember 13th, 2017

      It appears that CDRH has now resumed issuing guidances after not issuing any in the first six months of the new administration. In late August and early September CDRH has issued several final guidances, including “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical …

    • Rehearing Urged for Bad Ninth Circuit DecisionSeptember 10th, 2017

      In July, as reported here, the Ninth Circuit reversed the lower court’s decision to dismiss a False Claims Act (FCA) case against Gilead Sciences, Inc.  Not surprisingly, Gilead timely filed a petition for rehearing or rehearing en banc with the Ninth Circuit, and several groups submitted …

    • PhRMA and BIO Team Up Again to Challenge a State Drug Pricing LawSeptember 7th, 2017

      On September 1, 2017, two industry trade associations, Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Innovation Organization (“BIO”), jointly filed a civil action seeking declaratory and injunctive relief against the Nevada Governor and Director of the Nevada Department of Health and Human Services …

    • No Room for Camera Shyness: FDA Issues Another Warning Letter Citing Refusal to Permit PhotographyAugust 16th, 2017

      FDA seems to be getting bolder in penalizing industry when it prevents an FDA investigator from taking photographs during a routine FDA inspection. On August 2, 2017, FDA issued a Warning Letter to Homeolab USA Inc. (part of the parent company, Homeocan Inc. located in Montreal, …

    • ACI’s 5th Annual Paragraph IV Disputes Master SymposiumAugust 13th, 2017

      The American Conference Institute’s (“ACI’s”) 5th annual “Paragraph IV Disputes Master Symposium” is coming up! The conference will take place from October 2-3, 2017 at the InterContinental Chicago Magnificent Mile in Chicago, Illinois. ACI has put together an excellent program for conference attendees that include presentations from esteemed Judges …

    • The Supreme Court Refuses to Hear Park Doctrine CaseMay 23rd, 2017

      After a lengthy struggle that began with a major Salmonella outbreak in 2010, Jack and Peter DeCosters’ criminal case came to an end on May 22, 2017 when the U.S. Supreme Court denied their petition for writ of certiorari. We have followed this case with …

    • GAO Identifies Gaps in Oversight of Use of Medically Important Drugs in Food AnimalsMarch 23rd, 2017

      Antibiotic-resistant bacteria are claimed to be one of the biggest threats to global health, sickening an estimated 2 million people in the United States each year. There is evidence that some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, swine). …

    • FDA SOT Colloquium Explores Determination of Adversity in Food Chemical Safety EvaluationsMarch 21st, 2017

      On Monday, March 27, FDA and the Society of Toxicology (SOT) will present a colloquium (chaired by Bernadene A. Magnuson, PhD, Health Science Consultants, Inc., and Sabine Francke, DVM, PhD, CFSAN FDA) on Considerations for the Determination of Adversity in Food Chemical Safety Evaluations, the …

    • Oh Canada! Drug Importation Bills Look North to Address Accessibility and CostMarch 19th, 2017

      Oh Canada! Congress has decided that it’s once again time to start looking to our neighbors to the north for some help increasing accessibility and decreasing cost of prescription drugs.  With two new bills introduced in the last month, one in each chamber of Congress, …

    • “Chaos” Theory: Amgen’s SCOTUS Merits BriefMarch 14th, 2017

      On Friday, Amgen submitted its Opening and Response Brief at the Supreme Court in the matter of Sandoz v. Amgen, Nos. 15-1039, 15-1195.  The brief addressed two major questions with respect to the BPCIA: when an applicant can provide 180-day notice of biosimilar marketing and …

    • International Pharmaceutical and Medical Device Supply Chains Imperiled Like Never Before – A Webinar Presented by Dechert LLP and HP&MSeptember 5th, 2016

        In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. Furthermore, increased enforcement aimed at the medical …

    • Join Our Team: HP&M Seeks Two AssociatesJuly 11th, 2016

      Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks two attorneys to help with our fast-growing and robust practice.  The ideal candidate for one position is an attorney with substantive expertise in medical device regulation.    The other attorney is …

    • Federal Circuit Says BPCIA’s 180-Day Post-Licensure Notice Is Mandatory and Enforceable by Preliminary InjunctionJuly 7th, 2016

      By Andrew J. Hull & Mark I. Schwartz   On Tuesday, the U.S. Court of Appeals for the Federal Circuit affirmed a preliminary injunction against Apotex Inc. and Apotex Corp. (collectively, “Apotex”) related to Apotex’s biosimilar version of Amgen Inc. and Amgen Manufacturing Limited’s (collectively, “Amgen’s”) NEULASTA …

    • Long-Awaited Draft Guidances on Next Generation Sequencing Diagnostic Tests Released TodayJuly 7th, 2016

      By Allyson B. Mullen, Jeff N. Gibbs, McKenzie E. Cato* – Technological advances have resulted in Next Generation Sequencing (NGS) being used more and more frequently by diagnostic laboratories.  NGS in vitro diagnostics (IVDs) present a new set of regulatory and technical challenges for FDA and …

    • Join Our Team: HP&M Seeks Two AssociatesJuly 7th, 2016

      Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks two attorneys to help with our fast-growing and robust practice.  The ideal candidate for one position is an attorney with substantive expertise in medical device regulation.    The other attorney is …