FDA has released a new draft guidance for In Vitro Diagnostic Multivariate Index Assays (“IVDMIAs”). The first version, which was released on September 7, 2006, attracted many critical comments. The new draft seeks to address some (but not all) of those concerns. Creating a new …
After a highly anticipated revision of Medicare’s Clinical Trial Policy (“CTP”) that was issued in a July 9, 2007 Decision Memorandum (“Proposed Decision”) left many scratching their heads, the Centers for Medicare & Medicaid Services (“CMS”) issued a Proposed Decision Memorandum for Second Reconsideration of …
Support for legislation that would create a biogenerics approval path is reportedly crumbling. Last month, the Senate Health, Education, Labor, and Pensions (“HELP”) Committee passed S. 1695, “the Biologics Price Competition and Innovation Act of 2007.” Although neither the full Senate, nor the House Energy …
Before you do, be sure to become familiar with the Federal Trade Commission’s (“FTC’s”) regulation of the advertising of such products. Hyman, Phelps & McNamara attorneys Cassandra Soltis and John Fleder noted in an article for the Food and Drug Law Institute’s Update magazine that …
On Tuesday, July 17th, Hyman, Phelps & McNamara attorneys Michelle Butler and Jeff Wasserstein gave a teleconference, titled “False Claims Act Compliance Strategies: Don’t Lose Access to Medicare and Medicaid Reimbursement.” Audio copies of the teleconference, along with a transcript of the witty, yet thoughtful, …
Increasing cooperation between U.S. and European food and drug regulatory authorities are creating efficiencies for regulated industries and that benefit the public health. In two recent press releases, FDA announced that the European Medicines Agency (“EMEA”) has agreed to expand current regulatory cooperation with the …
On July 6, 2007, the Centers for Medicare & Medicaid Services (“CMS”) posted on its website a pre-publication copy of a final rule with a comment period to implement the Medicaid Rebate Program. The regulation, which finalizes a proposal that was published in the Federal …
We previously reported on a proposed rule issued by the U.S. Department of Agriculture (“USDA”) to amend the agency’s National Organic Program (“NOP”) regulations at 7 C.F.R. Part 205 to add 38 non-organic minor ingredients to the National List of Allowed and Prohibited Substances (“National …
Late Wednesday, the House of Representatives passed, by a vote of 403-16, H.R. 2900, “the Food and Drug Administration Amendments Act of 2007.” The Senate passed its version of omnibus FDA reform legislation in May 2007 — S. 1082, “the Food and Drug Administration Revitalization …
For the third time in as many years, FDA has been requested to provide an advisory opinion on the Agency’s policy for the submission of patents for Orange Book listing that cover drug delivery systems (e.g., metered-dose and dry powder inhalers, and transdermal patches) that …
In a July 3, 2007 filing with the Securities and Exchange Commission (“SEC”), Altus Pharmaceuticals Inc. announced that the company was notified by FDA’s Office of Orphan Products Development (“OOPD”) that the orphan drug designation granted in January 2002 to ALTU-135, also know as TheraCLEC, …
Positron Emission Tomography drugs, or PET drugs (not to be confused with drugs approved for companion animals), would be accorded more equitable user fee status under PDUFA IV if the Senate-passed version of the FDA Revitalization Act (“FDARA”) is signed into law. (A similar provision …
From the New York Times: “China executed its former top food and drug regulator today for taking bribes to approve untested medicine as Beijing scrambled to show that it is serious about improving the safety of Chinese products.”
On June 29, 2007, the U.S. District Court for the District of Columbia, in Mylan v. Leavitt, issued a memorandum opinion denying Mylan’s Emergency Motion for a Temporary Restraining Order that asked the court to order FDA to relist Pfizer’s U.S. Patent No. 4,879,303 covering …
On June 25, 2007, the Supreme Court agreed to hear Riegel v. Medtronic, Inc., which concerns whether the FDC Act preempts state tort claims regarding medical devices that entered the market pursuant to the Premarket Approval (“PMA”) process. In 1996, the Supreme Court held in …
