FDA Pharmaceutical and Medical Device Headline News

The German government’s draft law to reform the nation’s drug-pricing system has been referred to Parliament, where it faces hearings at the end of September.Read More

The Centers for Medicare & Medicaid Services (CMS) paid more than $43 million through Medicare Part D for “less-than-effective” (LTE) prescription drugs that should not have been covered, according to a report from the HHS Office of Inspector General.Read More

A major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program.Read More

After years of promises, the FDA says it plans to publish, within the next few months, a request for proposals (RFP) to begin the development and building of a unique device identifier (UDI) database.Read More

The FDA has approved Novartis’ Tekamlo, a pill containing its renin inhibitor Tekturna (aliskiren) and amlodipine (Pfizer’s Norvasc), as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals.Read More

As the FDA continues its internal deliberations on whether to keep GlaxoSmithKline’s (GSK) diabetes drug Avandia on the market, the agency’s internal Drug Safety Oversight Board (DSB) is not participating in the discussions because it hasn’t been asked by CDER officials to provide input, Steven Osborne, executive director of the board, said during a press briefing last week.Read More

Generic-drug makers will soon be required to follow GlaxoSmithKline’s (GSK) lead and update their labeling on generic versions of the company’s anticonvulsant Lamictal (lamotrigine) to reflect that, in rare instances, the drug can cause aseptic meningitis.Read More

Johnson & Johnson (J&J), which has come under scrutiny for quality problems with its drug units, is starting to experience similar problems with its device divisions.Read More

Trying to keep devicemakers, and the jobs they provide, in the U.S., lawmakers are urging the FDA to be more transparent and predictable in its review of 510(k)s.Read More

Sanofi-Aventis will continue its fight to keep generic versions of its blood thinner Lovenox off the market despite a federal court’s refusal to intervene in the matter.Read More

Drugmakers have until Oct. 30 to comply with new labeling provisions for medicines in the UK.Read More

Drugmakers will likely see new guidance and consensus standards on nanotechnologies in the near future as the FDA moves forward on its research and regulation of the technologies.Read More

Saudi Arabia will begin phasing in its marketing rules for devices this week, requiring manufacturers with products new to the country to apply to the State Food and Drug Administration (SFDA) for marketing authorization by Wednesday.Read More

In what could be a victory for the makers of pain pumps, an appellate court has affirmed a lower court’s ruling that there was not enough evidence to establish that a Breg pain pump caused a debilitating shoulder injury.Read More

Sun Pharmaceutical Industries has received a Form 483 for lack of assurance that the manufacturing process for its gemfibrozil 600-mg tablets is fully validated and will produce batches of consistent quality. Read More

Tired of waiting for a proposed rule to be released on a unique device identification (UDI) database, an advocacy group is asking the FDA to issue a regulation immediately.Read More

The FDA will soon begin inspections to determine companies’ compliance with electronic records guidelines under 21 CFR 11 (Part 11).Read More

A new study showing GlaxoSmithKline’s Avandia has cardiovascular (CV) risks similar to Takeda’s Actos may have come too late, as prescriptions for the embattled diabetes drug have plummeted as a result of the controversy.Read More

A group of economists is striking back against an FTC and Congressional Budget Office (CBO) argument that a ban on pay-for-delay settlements would bring generic drugs to market faster and save the federal government money, saying such a measure would actually have the opposite effect.Read More

Before transferring trial data to the sponsor, sites should make a certified copy and retain it for their records, according to the European Medicines Agency’s (EMA) final guidance on the use of electronic data in drug clinical studies. Read More

The FDA is debarring a Memphis ophthalmologist from clinical drug trials, but the agency does not have the authority to debar him as a device investigator.Read More

Although the Medical Device User Fee Act (MDUFA) won’t expire for two more years, devicemakers are being asked to begin negotiating with the FDA on the next incarnation of the bill at a public meeting Sept. 14.Read More

Pfizer’s Sutent missed its primary endpoint of overall survival in a Phase III clinical trial of advanced non-small cell lung cancer (NSCLC) patients, though the drug showed improvement in progression-free survival.Read More

The FDA plans to accept International Conference on Harmonisation (ICH) standards for bulk density and tapped density of powders as part of an ongoing harmonization project intended to reduce paperwork for drugmakers.Read More

Small biotechs developing drugs that potentially could be used in the event of a pandemic or public health emergency may receive help from the government.Read More

Citing unapproved changes and systemic failures ranging from nonconforming product to complaint handling, the FDA has asked Cincinnati Sub-Zero (CSZ) to have an external consultant audit its manufacturing and quality assurance systems.Read More

The debate over how the FDA should ramp up its regulation of laboratory-developed tests will continue, now that the agency has extended the comment deadline another month.Read More

EpiCept is considering filing under protest its NDA for the acute myeloid leukemia treatment Ceplene after the FDA refused to accept the submission.Read More

Apotex will be able to introduce a generic version of Daiichi Sankyo’s dry-mouth treatment Evoxac in the fourth quarter of 2012 following a settlement in a patent infringement case.Read More

A federal judge has ordered Watson Pharmaceuticals CEO Paul Bisaro to testify in the ongoing FTC investigation into an alleged pay-for-delay deal between the company and the brand-drug maker CephalonRead More

While principal investigators may delegate many of the duties involved in conducting a clinical trial, they cannot delegate their responsibility to adequately supervise the trial.Read More

To keep up with the reality of wireless medical technology, the FDA and Federal Communications Commission must make more effort to globalize medical telemetry bands, evaluate threats to patient safety and clarify current regulations.Read More

A joint FDA advisory panel meeting voted 20–2 against recommending that the agency approve Jazz Pharmaceuticals’ bid to expand the indication for sodium oxybate to include treatment of fibromyalgia.Read More

A federal judge has granted a temporary injunction barring generic-drug makers from making versions of Eli Lilly’s attention-deficit treatment Strattera while the company considers an appeal of a ruling invalidating its patent on the drug.Read More

Cardiome Pharma is delaying the start of a late-stage trial of its atrial fibrillation drug vernakalant so it can design a Phase III program that will position it to better compete with Sanofi-Aventis’ Multaq (dronedarone HCl).Read More