 FDA to Judge: Enforcement Decisions Are DiscretionaryBlocking 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
Ohm Labs Gets 483 for Failure to Address Blue GlassRanbaxy 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
TGA Clarifies Implant Reclassification FeesManufacturers 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
FDA Wants Basic Testing, Stronger Warnings on Tanning Bed LampsMakers 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
Q&A Guidance Documents Address IND Access, ConcernsThe 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
Novartis Gets 483 for Batch Quality Control Process FlawsThe 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
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TGA Clarifies Implant Reclassification FeesManufacturers 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
FDA Wants Basic Testing, Stronger Warnings on Tanning Bed LampsMakers 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
Standardized Device Labeling Still an Undefined Concept: StakeholdersDesigning 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
China Considering Fast-Track Pathway for Novel Medical TechnologiesThe China Food and Drug Administration (CFDA) has drafted two measures aimed at expediting approval processes for medical devices. Read More
Medtronic Appeals $73.5M Edwards Patent Win to Supreme CourtMedtronic 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
IVD Makers Face ‘Quantum Leap’ in Requirements Under Proposed EU RegIn 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
Ohm Labs Gets 483 for Failure to Address Blue GlassRanbaxy 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
Q&A Guidance Documents Address IND Access, ConcernsThe 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
GOP Track-and-Trace Bill Moves to House Floor Without Unit-Level DesignsA 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
Draft EMA Guideline Sets Biosimilar Groundwork, Clinical Study ComparisonsThe 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
Report Pokes Holes in FDA Celexa Dose WarningThe 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
Tenth Annual Medical Device Quality Congress
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