 FDA, USP Enlist Industry’s Help in Improving OTC Drug QualityFDA 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
Report Points to Steep Four-Year Rise in Device Warning LettersThe 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
Anvisa Harmonizes Device, IVD GMPsBrazil 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
‘Significant Decision’ Clarified in CDRH Appeals GuidancesCDRH 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
Biotest Recalls Biologic Drug Due to ParticlesJust 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
Ranbaxy and Justice Settle Manufacturing Compliance CaseGeneric 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
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Report Points to Steep Four-Year Rise in Device Warning LettersThe 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
Anvisa Harmonizes Device, IVD GMPsBrazil 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
‘Significant Decision’ Clarified in CDRH Appeals GuidancesCDRH 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
Philippines Revises Registration PolicyThe 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
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
Biotest Recalls Biologic Drug Due to ParticlesJust 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
Ranbaxy and Justice Settle Manufacturing Compliance CaseGeneric 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
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
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
Tenth Annual Medical Device Quality Congress
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