A U.S. senator is asking the U.S. Food and Drug Administration to respond to accounts that an internal drug safety oversight board voted earlier in October to keep GlaxoSmithKline’s diabetes drug Avandia on the market by a one-vote margin amid agency considerations of a second warning for the drug label about heart attack risks.
Blood-bank instruments maker Immucor Inc. said Friday that it had received a request from the U.S. Federal Trade Commission for information related to acquisitions it made about a decade ago.
Amid growing concerns over the safety of Avandia, the U.S. Food and Drug Administration is reportedly pushing for the diabetes drug's manufacturer GlaxoSmithKline PLC to add an additional so-called “black box” warning about heart-attack risk to the label.
The U.S. Food and Drug Administration is planning public hearing on whether it should revise its current rules for salt and sodium, the agency said in an announcement published in the Federal Register Tuesday.
Earlier this fall, a spotlight brightened on a larger issue as the U.S. Food and Drug Administration banned prescription cold and cough medications: Thousands of drugs are on the market that have never gone through proper approval channels.
The U.S. Food and Drug Administration said Thursday that it has approved labeling changes for three popular erectile dysfunction drugs to better warn consumers about a possible risk of sudden hearing loss.
An appellate panel on Thursday revoked AstraZeneca Plc's European combination patent for the asthma treatment Symbicort, well over two years after the European Patent Office upheld its validity.
A week after numerous drug makers pulled infant cough and cold medicines off shelves, expert advisers to the U.S. Food and Drug Administration kicked off meetings today to discuss a petition that would ban such over-the counter medicines for children below the age of 6.
The Federal Trade Commission warned a congressional committee on Thursday that granting community pharmacists an antitrust exemption to negotiate collectively with health plans would ultimately hurt consumers.
Several leading drug manufacturers are voluntarily pulling over-the-counter infant cough and cold medicines from the shelves after two studies found that hundreds of toddlers had been injured and even killed by the products.
In a blow to a Novartis AG subsidiary, the U.S. Patent and Trademark Office has issued a final interference decision striking down a patent covering technology for detecting HIV in the blood.
California Gov. Arnold Schwarzenegger released revised details of his statewide health care reform bill on Tuesday and proposed using the California lottery to help pay the tab.
The U.S. Patent and Trademark Office has revised its examination guidelines in light of the U.S. Supreme Court decision in KSR International v. Teleflex Inc., which made it easier to invalidate patents based on obviousness.
Drug maker Eli Lilly and Co. has decided to put stronger product labels on its blockbuster antipsychotic treatment Zyprexa, adding new warnings about the potential for weight gain and elevated blood sugar or cholesterol levels.
The U.S. Food and Drug Administration has unveiled a new program designed to speed up the process of getting generic drugs approved and to hasten the market entry of the less expensive generics.
The U.S. Federal Trade Commission has given the green light to pharmaceutical company Mylan Laboratories' $6.6 billion acquisition of generic-drug maker E. Merck OHG, but the commission forced the companies to sell five generic drugs they currently produce due to competition concerns.
The millions of patients that enroll in clinical trials for experimental drugs and medical devices each year are rarely watched over or protected by the U.S. Food and Drug Administration, a federal investigator has found.
The U.S. Food and Drug Administration on Friday ordered that all prescription drugs that contain hydrocodone and have not received FDA approval be removed from the market.
President George W. Bush signed legislation Thursday that renews the U.S. Food and Drug Administration's ability to charge fees for considering drugs for approval, alters the citizen petition process for generic drugs and strengthens drug safety.
The U.S. Food and Drug Administration issued a public health notice Wednesday that warned health care professionals and consumers about the dangers of Cephalon Inc.'s pain drug Fentora.
In a case speaking to the issue of the enforceability of protective orders, the U.S. Court of Appeals for the Second Circuit upheld an injunction against an attorney who conspired with an expert witness to avoid compliance with an order. The court made it clear that parties who conspire to avoid a protective order are subject to jurisdiction in the court where the protective order is enforceable, say Gretchen M. Callas and Kellie Clark of Jackson Kelly PLLC.
Plaintiffs attorneys relish the opportunity to put company CEOs under oath in a deposition. These depositions can generate negative publicity and powerful damning evidence for trial or settlement leverage when the depositions do not go well. They can also significantly bolster claims for punitive damages, say Michael J. Vanselow and Venora Hung of Oppenheimer Wolff & Donnelly LLP.
In a trio of recent Pennsylvania Superior Court decisions involving the diet drug Redux, plaintiffs lawyers may have gained a new cause of action against pharmaceutical manufacturers, but not before the reaffirmance of the learned intermediary defense and the rejection of a plaintiff's unique challenge to that defense, say Alan Klein and Fletcher W. Moore of Duane Morris LLP.
Getting a law degree is no longer the default safety net it once may have been, even though incoming students do not yet seem to understand that. Some large firm partners have expressed the view that law firms in fact subsidize law schools, says Kate Neville of Neville Career Consulting LLC.
No lawsuits have yet been filed relating to environmental, health or safety effects relating to nanomaterials. Nonetheless, the associated risks create the potential for mass tort litigation involving bodily injury, property damage, financial loss and third-party liability, says Ethan V. Torrey of Choate Hall & Stewart LLP.
The Fourth Circuit in North Carolina v. Tennessee Valley Authority joins the many other courts that have held that unless substances exceed regulatory levels, there can be no action for nuisance. In so holding, the Fourth Circuit has gone further than any other court to date in articulating the strong legal and public policy basis for such a rule, say J. Kevin Buster and Randy J. Butterfield of King & Spalding LLP.
The complexity of crafting an inequitable conduct pleading has greatly increased since Exergen. Likewise, courts may now find it more difficult to assess the sufficiency of post-Exergen inequitable conduct pleadings since they now include an enormous amount of information in the awkward paragraph pleading format used in federal courts, says Gary J. Fischman of Howrey LLP.
The Drug Safety and Accountability Act of 2010 may be aligned with just the right factors — a conducive regulatory atmosphere and public concern over foreign drug safety — for the bill at least to make it out of committee, say Christin Garcia and Christine Kain of Faegre & Benson LLP.
Conventional wisdom says that anti-piracy programs at corporations, particularly in the health care sector, represent a necessary evil: a costly effort that must be undertaken to protect the integrity of the brand and deter counterfeiters. But that is far from the only way to view brand protection efforts, say Geoffrey R. Kaiser, Richard T. Faughnan and Todd J. Marlin of Navigant Consulting.
Many attorneys will argue that fixed-fee billing arrangements are impossible to implement, that they're too risky and involve too many variables. Here's why they're wrong, say William A. Rudnick and Keith Maziarek of DLA Piper.