FDA Pharmaceutical and Medical Device Headline News

All eyes will be on California this week as it joins a growing list of states trying to decide how to regulate the substitution of biosimilar drugs for their more costly brand counterparts.Read More

GOP House leaders are investigating the brief tenure of Leona Brenner-Gati in the wake of the former FDA acting deputy commissioner’s sudden departure earlier this month.Read More

Goldman Sachs last week announced plans to invest about $20 million in Indian devicemaker BPL Medical Technologies, marking one of the largest medtech investments made to date in an emerging market.Read More

Deborah Autor, U.S. Food and Drug Administration deputy commissioner for global regulatory operations and policy, is leaving to join the regulatory policy team at generic drugmaker Mylan.Read More

Following weeks of speculation, Actavis said Monday it will acquire Warner Chilcott in an all-stock transaction valued at $8.5 billion.Read More

Asada Milling, a Japanese maker of active pharmaceutical ingredients (API), has been warned by the FDA for a general lack of quality control — and cleanliness — at its facility located in Gunma, Japan. Read More

A federal judge handed Shire a victory May 9, ruling that Actavis’ generic version of Lialda, indicated for ulcerative colitis, infringed the company’s ‘720 patent.Read More

The FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds.Read More

Brazil is streamlining its good manufacturing practice requirements, replacing RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostics with a single regulation, RDC 16/2013.Read More

CDRH Friday released two guidances aimed at clarifying the center’s appeals process and bringing it in line with last summer’s FDA Safety & Innovation Act.Read More

FDA and U.S. Pharmacopeial Convention (USP) officials say proactive industry participation — mainly by offering up drug samples and technical information — is vital to improving the quality of OTC finished drugs, the subject of recent high-profile recalls.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

Generic drugmaker Ranbaxy announced May 13 it has agreed to a $500 million settlement with the Department of Justice following allegations of poor data integrity and manufacturing practices at three of its Indian facilities and a facility in Upstate New York.Read More

The Philippines has completed the transfer of regulatory authority for medical devices from the Food and Drug Administration to the Center for Device Regulations, Radiation Health and Research.Read More

Blocking imports of every shipment of active pharmaceutical ingredient intended for compounding is an impossible feat requiring resources beyond the FDA’s means, the agency told an appeals court last week, calling KV Pharmaceuticals’ claims it should have done so “absurd.” Read More

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

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