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Counting to 60 – A Task that is Perhaps More Difficult than One Might Think; AstraZeneca Cries Foul Over PTE Application Timeliness Calculation Method
…(“the ‘338 patent”), which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a PTE on the same two statutory bases. In both cases, AstraZeneca has challenged…
The “Dog Ate My Homework Act” Resurfaces
…Reform Act of 2007” (S. 1145) by Senator Edward Kennedy (D-MA). Representative William Delahunt (D-MA), who introduced a stand-alone bill earlier this year in the House, H.R. 1778, is trying…
A Noteworthy Event for the Drug and Device Industries
…in the drug/biological product approval process SEE the importance of cGMPs to the post-approval regulatory process NAVIGATE the protocols of adverse events monitoring, pharmacovigilance, and Risk Evaluation and Minimization Strategies…
A Noteworthy Fraud and Abuse Compliance Event for the Medical Device Industry
…legal parameters of DTC marketing, including “new media” TRACK state legislative initiatives and HARMONIZE inconsistent state obligations Additional details and registration information are available at www.AmericanConference.com/MedicalDevices or by calling 888-224-2480….
Up, Up and But Not Away: DEA Raises Registration Fees
…Mid-Level Practitioner $731 $888 $157 Current and New Fees for Annual Cycle Registrants Registrant Category Current Annual Fee New Annual Fee Increase Per Year…
PTO’s ANGIOMAX PTE Denial is Vacated and the Case Goes Back to PTO – What Happens in the Interim?
…notice of NDA approval of the drug product if that transmittal occurs after normal business hours. In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that…
The Government Really Means It This Time (Part II)
…criminal charges against individuals without the express approval of the U.S. Attorney or Assistant Attorney General who handled the investigation. Although declination memoranda are not atypical, this mandatory requirement to…
Do You Really Want to Be An Executive In An FDA-Regulated Company?
By James R. Phelps – Last Thursday, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division, Benjamin Mizer,…
House Bill Targets Teenage Dextromethorphan Abuse
…military personnel; Requiring retailers to verify that they are not selling dextromethorphan to individuals under 18 years old and to implement a verification system through an electronic point-of-sale prompt to…
Hi-Tech Executives End Up in Jail; District Court Imposes Incarceration as a Coercive Sanction in Civil Contempt Proceedings
…alleging that defendants, including the National Urological Group, Inc., Hi-Tech Pharmaceuticals, Inc., Jared Wheat and Stephen Smith, violated the FTC Act by marketing various dietary supplements with unsubstantiated weight loss…
FDA Issues Draft Guidance Document Interpreting FDC Act § 505(q) – “Petitions and Civil Actions Regarding Approval of Certain Applications”
…request an action that could delay approval of a pending ANDA or 505(b)(2) application. If the action requested by the petition could not delay approval of the application under any…
A New Attack in the Opioid Crisis: “First of its Kind” Motion for an Ex Parte Temporary Restraining Order and Complaint Against Two Tennessee Pharmacies and Their Pharmacists, Alleging Unlawful Opioid Dispensing and False Claims Act Violations
…a need to immediately halt illegal activities, and an alleged real threat that defendants would continue to violate the Controlled Substances Act and harm the public. Defendants allegedly violated their…
DOJ Settles with Five Hip and Knee Replacement Companies
…Stryker Orthopedics, Inc.) resolving anti-kickback allegations. The allegation common to all five cases is that each of the companies entered into consulting agreements with orthopedic surgeons under which the companies…
CDRH Issues Report on Improvements in Device Review
…in January 2011. The report states that since the Plan of Action, “the speed and predictability of device review have improved for the first time in almost a decade, including…
FDA and FTC Announce New Steps Under the Biosimilars Action Plan, Which Include Targeting False and Misleading Statements About Biosimilars
…presenting studies that were conducted in support of reference product approval in biosimilar promotional materials, presenting data in promotional material derived from biosimilarity studies that are not part of the…