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Theqmnweeklybulletin

Oct. 12, 2012

Vol. 4 No. 41

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Inadequate Labeling on Ophthalmic Drugs Draws Warnings for Akorn, Bausch + Lomb

Akorn and Bausch + Lomb have received warning letters from the FDA for marketing unapproved ophthalmic drugs containing pilocarpine hydrochloride at various strengths. Read More

FTC Releases Guideline on Privacy, Advertising of Mobile Apps

Developers of medical device mobile apps don’t just need to worry about the FDA’s advertising and promotion regulations, they also must ensure any marketing claims comply with a new FTC guideline. Read More

India Draft Guidance Aims at Better Control of Biologics During Transport, Storage

Distributors of biological products must maintain records of temperature monitoring data and check temperatures during transport and storage at defined intervals, according to a draft guidance by India’s Central Drugs Standard Control Organization (CDSCO). Read More

FDA Warns CardioMEMS for Recommendations to Investigators

The FDA handed Atlanta-based CardioMEMS a warning letter for deviations related to a clinical investigation and premarket approval application (PMA) for its CardioMEMS HF Pressure Measurement System. Read More

FDA Warns Epimed International for Supplier Control, Procedural Issues

Lax process and quality control of supplied components helped land Irving, Texas-based Epimed International an FDA warning letter. Read More

Specification Concerns Prompt Recall, MHRA Alert on Sanofi Pasteur Typhoid Vaccine

Sanofi Pasteur MSD, a Merck-Sanofi vaccine venture, is recalling 16 batches of its typhoid vaccine Typhim Vi after recent investigations found some syringes may have sub-potent antigen levels, the Medicines and Healthcare products Regulatory Agency (MHRA) says. Read More

Cispharma Gets Form 483 Over Testing, Drug Quality Concerns

Cispharma has received a Form 483 with several manufacturing observations, including a lack of evidence that a distributed portion of a lot was acceptable. Read More

Stryker Waste Management System Recalled After Injuries, Death

Reports of two serious injuries, including one fatality, prompted Stryker to issue a Class I recall of the Neptune Waste Management System. Read More