It’s that time of year again when we at FDA Law Blog turn to our loyal readers and say: “Our fellow Blogerians, Ask not what your blog can do for you – ask what you can do for your blog.” Yes, the American Bar Association …
Menu
Uncategorized
- Looking For a Three-Peat – The ABA Blawg 100August 22nd, 2011
- California Court Allows Case Against Homeopathic Drug Manufacturer to ProceedAugust 9th, 2011
By Susan J. Matthees – Apparently as a result of a misunderstanding of the basic principles of homeopathy, and how of necessity the efficacy testing for such drugs differs from non-homeopathic drugs, a judge in the U.S. District Court for the Central District of California recently decided …
- No End to Aggressive Investigative TechniquesJuly 7th, 2011
By Anne K. Walsh & John R. Fleder – Companies must proactively prepare for the strong arm tactics the government employs to investigate companies regulated by FDA. A recent case demonstrates that the federal government can act with little regard to companies seeking to represent themselves by …
- FDA Gets the Ball Rolling on Biosimilar/Interchangeable Biological Product User Fee Program; Proposal Gives a Hat Tip to PDUFA While Acknowledging the Nascent State of the IndustryMay 9th, 2011
By Kurt R. Karst – On May 9th, FDA announced the May 10th publication of a Federal Register notice proposing and requesting comment on the structure of a user fee program for applications for biosimilar and interchangeable biological products submitted under section 351(k) of the Public …
- FDA Moves to Limit Maximum Dosage Strength of Acetaminophen in Prescription Combination Drug Products and Requires Labeling ChangesJanuary 13th, 2011
By Susan J. Matthees – FDA is announcing that it is taking steps to reduce the maximum dosage strength of acetaminophen in prescription combination products to 325 mg in a single dosage unit. The Agency will also require safety labeling changes, including a boxed warning, for …
- FDA Proposes to Update Phytosterols Health Claim and Announces Change in Exercise of Enforcement DiscretionDecember 13th, 2010
By Riëtte van Laack – FDA published a proposed rule that would amend the regulation governing the use of health claims for phytosterols and coronary heart disease. In 2000, FDA issued an interim final rule ("IFR"), 21 C.F.R. § 101.83, for health claims concerning the relationship …
- Solicitor General Files Amicus Brief in Mensing Cases on Generic Drug Preemption; Recommends that the Supreme Court Deny ReviewNovember 3rd, 2010
By Kurt R. Karst – Hot off the presses! The U.S. Department of Justice (Solicitor General of the United States) filed its highly anticipated amicus brief in response to the U.S. Supreme Court’s invitation to weigh in on generic drug preemption. The Court’s request was made in the context …
- U.S. Sentencing Commission Adopts Amendments to Organizational Guidelines But Does Not Adopt Changes That Would Have Negatively Impacted Companies Regulated by FDAMay 4th, 2010
By Peter M. Jaensch – On Friday, April 30th, 2010, the U.S. Sentencing Commission sent Congress amendments to the federal Sentencing Guidelines applicable to organizations such as corporations. On January 21, 2010, we reported on proposed changes to the federal Sentencing Guidelines. The changes would have apparently …
- President’s Working Proposal for Health Care Summit Contains Familiar Drug and Device ProvisionsFebruary 22nd, 2010
By Alan Kirschenbaum — In an effort to salvage health care reform, the Obama Administration will hold a bipartisan health care reform meeting this Thursday, February 25. Invited are the Congressional leadership of both parties and the Chairmen and ranking membership of committees involved in health …
- Proposed Rule Requires Sponsors to Report Suspected Falsification of Data to FDAFebruary 19th, 2010
By David B. Clissold and Nisha P. Shah On February 19, 2010, FDA issued a proposed rule that would require sponsors to report any person that has or may have engaged in the falsification of data in studies that involve human or animal subjects. FDA believes …
- FDA Injects A Wrinkle into Botox MarketingMay 4th, 2009
By Carrie S. Martin – FDA announced on April 30, 2009, that all botulinum toxin products will now require a Risk Evaluation and Mitigation Strategy ("REMS") and safety labeling changes, including a boxed warning, due to the risk of spread of botulinum toxin effects from …
- FDA Stays the Course on NanotechnologyFebruary 19th, 2009
By Ricardo Carvajal— During a session at the Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, senior FDA staff confirmed that the agency does not intend to issue regulations specific to products derived through nanotechnology, or to establish a definition …
- DEA Proposes Placing of Tapentadol Into Schedule IIFebruary 18th, 2009
By John A. Gilbert and Larry K. Houck – The Drug Enforcement Administration (“DEA”) has published a notice of proposed rulemaking to control Tapentadol as a schedule II substance under the Controlled Substances Act. Schedules of Controlled Substances: Placement of Tapentadol Into Schedule II, 74 Fed. Reg. 7,386 …
- ACCESS Act Reintroduced by Sen. Brownback; Previous Tiered Approval Nomenclature Scrapped and New Immunity Provision AddedJune 4th, 2008
In late May, Senator Sam Brownback (R-KS) introduced S. 3046 – the “Access, Compassion, Care, and Ethics for Seriously Ill Patients Act” (the “ACCESS Act”). The bill, which is similar to legislation Sen. Brownback introduced in the 109th Congress with the same title (i.e., S. …
- FDA Law Blog Turns One! What a Year It Has Been! Thank You!March 6th, 2008
One year ago today, Hyman, Phelps & McNamara, P.C., started FDA Law Blog with this post and a promise to provide you with timely updates on FDA enforcement actions, proposed rules, personnel changes, new and improved policies, along with related issues such as healthcare fraud …