The QMN Weekly Bulletin

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

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.

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temperature monitoring data and check temperatures during transport and storage at defined intervals, according to a draft guidance by India’s Central Drugs Standard Control Organization (CDSCO).

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.

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

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.

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

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