By Cassandra A. Soltis – FDA has posted on its web site two revised draft guidance documents (here and here) concerning the labeling requirements of dietary supplements and over-the-counter (OTC) drugs under the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006. That Act …
By Susan J. Matthees – FDA recently announced the availability of a new draft guidance document on the types of information FDA recommends be included in a complete submission for the evaluation of proprietary names for prescription drug products, biologics, and nonprescription drug products that …
By Bryon F. Powell – On November 26, 2008, the Massachusetts Department of Public Health delayed plans to propose emergency regulations that would implement the state’s recently enacted pharmaceutical and device marketing law at a December 10 meeting of the Public Health Council. A pair …
By Michelle L. Butler – We previously posted on the expanded certification requirements mandated by section 102(a)(1) of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”). Today, the Consumer Product Safety Commission (“CPSC”) published on its website an immediate final rule regarding these certification …
By James R. Phelps – On November 7, 2008, the First Appellate District in the Court of Appeal of the State of California, which sits in San Francisco, issued a remarkable decision in Conte v. Wyeth, Inc. The court said: “We hold that the common law …
By Kurt R. Karst – Commissioner Pamela Jones Harbour of the Federal Trade Commission (“FTC”) recently gave a speech, titled “The Federal Trade Commission’s Perspective on Biosimilars: Current Initiatives and Long-Term Goals.” This is at least the second speech in which Commissioner Harbour has address …
By Kurt R. Karst – Your loyal and intrepid bloggers were in attendance at today's argument before the U.S. Supreme Court in Wyeth v. Levine. The case has been billed by some as the business case of the century; however, we think such hype is …
By Kurt R. Karst – Happy Halloween! Earlier this week, Health News Daily reported that Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, was named a permanent member of FDA’s Drug Safety and Risk Management Advisory Committee. A copy of Dr. Wolfe’s Curriculum …
By Ricardo Carvajal & Kurt R. Karst – On October 28, 2008, FDA announced that the Agency issued Warning Letters to Bayer HealthCare contending that two of Bayer’s products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage (Heart Advantage), are unapproved …
By Anne Marie Murphy — We recently posted on the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), which makes a number of changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”). Section 102(a)(1) of CPSIA amends the Consumer Product Safety Act (“CPSA”) …
Last week, I presented at the Center for Business Intelligence’s Pharmaceutical Congress on Paragraph IV Disputes with Geoff Levitt of Wyeth on citizen petitions. The focus of my talk was on new FDC Act § 505(q) – “Petitions and Civil Actions Regarding Approval of Certain …
On October 20, 2008, FDA announced the availability of a highly anticipated draft guidance document, titled “Tropical Disease Priority Review Vouchers.” The draft guidance discusses FDA’s implementation of FDC Act § 524 – “Priority Review to Encourage Treatments for Tropical Diseases” – which was added …
FDA’s Office of Combination Products (“OCP”) recently released a draft guidance entitled “New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products.” The draft guidance permits diagnostic imaging device makers to expand labeling for use with a contrast agent or radiopharmaceutical even …
FDA recently published a new draft guidance document on potency tests for cellular and gene therapy (“CGT”) products. The FDC Act requires that all biological products meet agency requirements for safety, purity, and potency before such products will be approved, but historically the agency and …
On October 2, 2008, the Consumer Product Safety Commission (“CPSC”) held a public meeting on the testing and certification requirements imposed by the recently enacted Consumer Product Safety Improvement Act (“CPSIA”). A similar meeting was held on September 4, 2008 and several others are planned …
