Drug Manufacturers, FDA | JD Supra Law News

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

by Ellen Adler, James W. Huston, Joanna Simon | Morrison & Foerster LLP on 5/16/2013

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

Business Litigation Report -- April 2013

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/15/2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

Intellectual Property Bulletin - Winter 2013

by Ewa Davison, R.J. Heher, David Marty, David Tellekson, Jedediah Wakefield, Elizabeth White, Lauren Whittemore, Sean Wikner | Fenwick & West LLP on 4/4/2013

In This Bulletin: - Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case - Murky Waters: Post-Approval Regulatory Activities and the §...more

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 3/15/2013

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more

CMS Issues Final Rule for Implementing Sunshine Act

by Wilson Sonsini Goodrich & Rosati on 2/14/2013

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

No Standing for Illegal Drugs: Third Circuit Limits Antitrust Standing for Foreign Drug Manufacturers Absent FDA Approval

by Bill Devinney | BakerHostetler on 2/7/2013

A Third Circuit panel recently ruled that a foreign drug manufacturer lacks antitrust standing when it could only sell its product in the United States through a distributor....more

Chinese FDA Imposes Mandatory Electronic Barcoding on Imported Drugs

by Katherine Wang | Ropes & Gray LLP on 2/5/2013

The State Food and Drug Administration (“SFDA”) issued a Notice on Relevant Issues Concerning Imposing Electronic Barcoding on Imported Drugs (“Notice”) on January 29, 2013 with immediate effect. Pursuant to the Notice,...more

FDA Issues Final Rule Regarding CGMPs for Combination Products

by King & Spalding on 2/4/2013

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

by Erin M. Bosman, Julie Y. Park, Joanna Simon | Morrison & Foerster LLP on 1/15/2013

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

Uncertainty Regarding the Future Regulation of Compounding Pharmacies

by Fuerst Ittleman David & Joseph, PL on 1/14/2013

As we previously reported, the nationwide outbreak of fungal meningitis linked to contaminated injections produced by New England Compounding Center (“NECC”), a compounding pharmacy in Framingham, Massachusetts, prompted...more

Chinese FDA Unveils Plan for Regulatory Reform

by Katherine Wang | Ropes & Gray LLP on 1/9/2013

The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

by Fuerst Ittleman David & Joseph, PL on 12/17/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

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Drug Manufacturers › The United States Food and Drug Administration