FDA Pharmaceutical and Medical Device Headline News

Ranbaxy subsidiary Ohm Laboratories received a Form 483 for quality control lapses surrounding blue glass in the active pharmaceutical ingredient for atrovastatin calcium tablets.Read More

Manufacturers transitioning hip, knee or shoulder joint replacement implants to Class III will not have to pay the US $1,190 annual application fee until July 1 2014, if the application is approved before June 30, 2013 and the Class IIb listing on the Australian Register of Therapeutic Goods is removed.Read More

Makers of ultraviolet sunlamps used in tanning beds would have 15 months to submit 510(k)s demonstrating safety, if an FDA proposed rule takes effect.Read More

The FDA on May 8 issued two draft question-and-answer guidances intended to clear up industry confusion about how it charges patients for INDs during clinical trials and how it expands access to such drugs outside of the clinical arena. Read More

The method Novartis uses to clear batches at its Suffern, N.Y., facility was deemed inadequate by FDA investigators, resulting in a Form 483.Read More

Companies drafting a social media policy in anticipation of upcoming FDA guidance should try to follow the same general guidelines used for traditional marketing materials, experts advise.Read More

The FDA has warned GRI Medical & Electronic Technology for corrective and preventive action (CAPA) shortfalls and its handling of nonconforming product.Read More

Just two months after its first commercial sale, Biotest Pharmaceuticals has voluntarily recalled one lot of its immunodeficiency drug Bivigam due to visible particles.Read More

A House committee on Wednesday advanced legislation establishing a national track-and-trace system for pharmaceuticals despite vociferous Democratic objections over the bill’s immediate preemption of state laws and lack of a clear unit-level pedigree roadmap.Read More

The European Medicines Agency (EMA) on May 2 published draft guidelines aimed at facilitating global development of biosimilars and avoiding unnecessary repeats of clinical trials.Read More

The FDA’s 2011 about-face on Forest Laboratories’ antidepressant Celexa, in which the agency warned against taking the drug at doses higher than previously approved, is being challenged by a group of researchers who say the warning may do more harm than good.Read More

Designing device labeling that customers will use remains a challenge due to the lack of any standardized terminology and framework, stakeholders at a recent two-day FDA workshop said.Read More

The China Food and Drug Administration (CFDA) has drafted two measures aimed at expediting approval processes for medical devices. Read More

French drugmaker Sanofi-Aventis was fined $52.6 million by the French competition authority Tuesday for marketing practices that discouraged sales of generic versions of the company’s blood thinner Plavix.Read More

Acting on fresh health-risk assessments, the European Medicines Agency’s pharmacovigilance panel is calling for an EU-wide suspension of tetrazepam-containing drugs and recommending new restrictions on the use of a pair of French-made osteoporosis drugs.Read More

Industry stakeholders will have an opportunity to shape the FDA’s fiscal 2014 regulatory science roadmap for generic drugs during a June 21 public meeting at the agency’s headquarters.Read More

Medtronic has asked the Supreme Court to hear an appeal in a $73.5 million patent infringement judgment against the company won by Edwards LifeSciences.Read More

In vitro diagnostic manufacturers can expect a “quantum leap” in regulatory burden if the European Commission’s proposed IVD regulation is adopted — a 180-degree turn in notified body requirements, a device legal expert says.Read More

The White House Monday sought to block a lower court judge’s order requiring the FDA to remove all age restrictions from the emergency contraceptive known as Plan B One-Step.Read More

Alexion is reviewing its analytical methodologies and procedures to ensure its risk assessments meet the FDA’s expectations, the drugmaker said. Read More

The European Commission should specify provisions for inspecting clinical trials of in vitro diagnostic devices and not leave oversight to the discretion of EU member states, a draft report by a member of Parliament says.Read More

The European Medicines Agency released a first revision of good pharmacovigilance practice guideline, adding practical instructions for the application, description and maintenance of the EU reference date list in — and amendments to — marketing authorizations.Read More

Devicemakers that want their voices heard as the European Parliament considers reforms to medical device regulation need to speak up immediately, experts urge.Read More

A federal judge Friday declined the Obama administration’s request to issue a stay pending appeal of his decision that would lift age and identification restrictions on Teva’s OTC emergency contraceptive Plan B One-Step.Read More

A growing number of pivotal clinical trials — typically Phase III studies — submitted in support of drug applications in Europe are being conducted outside the region, a European Medicines Agency report finds.Read More

To improve engagement between the European Medicines Agency, drugmakers and scientific committees, the agency is putting in motion planned changes discussed late last year.Read More

The FDA’s failure to release a final rule on unique device identification by last week’s deadline could delay efforts by other branches of government to put UDIs into use, according to lawmakers.Read More

The International Medical Device Regulators Forum last month unveiled its long-awaited plan for device identification, pushing for a “highly interoperable” and harmonized system to globally track medical devices. Read More

CDER Director Janet Woodcock, appearing before a Senate panel Thursday, reiterated the FDA’s call for enhanced authority to seize compounding pharmacy records.Read More

Improved transparency and better access to biosimilars and orphan drugs are key goals in an emerging blueprint for industry being developed by a panel of European pharma stakeholders.Read More

In an effort to reduce filing errors, the FDA has launched a pilot program for the electronic submission of field alert reports (FARs) using the XML data format.Read More

CareFusion has reached an agreement in principle to pay the government $41 million, resolving investigations into sales and marketing of its ChloraPrep skin preparation.Read More

Oral arguments are set for May 15 in a suit pending in the D.C. Circuit Court of Appeals that seeks to overturn the U.S. Securities & Exchange Commission’s (SEC) conflict minerals disclosure requirement.Read More

The FDA has warned two makers of speech therapy devices for quality system issues, as well as for lacking device approvals or clearances.Read More

The European Commission should specify provisions for inspecting clinical trials of in vitro diagnostic devices and not leave oversight to the discretion of EU member states, a draft report by a member of Parliament says.Read More