Regulatory Roundup: Week of October 1, 2012

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FDA launches BeSafeRx program and releases guidance for industry.

FDA has launched BeSafeRx—Know Your Online Pharmacy, a national campaign designed to promote public awareness of fraudulent Internet pharmacies. The program offers consumers resources for educating themselves on FDA’s website at FDA warns that fake online pharmacies use sophisticated marketing tricks and that “less than 3% of online pharmacies meet state and federal laws.” FDA recommends consumers only purchase from online pharmacies located in the United States that require a valid doctor’s prescription, have a licensed pharmacist available, and are licensed with a state board of pharmacy.

FDA has released the following guidance documents:

Guidance for Industry, Acute Bacterial Otitis Media: Developing Drugs for Treatment (September 2012).

Guidance for Industry, Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment (September 2012).


Guidance for Industry, Complicated Intra-Abdominal Infections: Developing Drugs for Treatment, Draft Guidance (September 2012).

Guidance for Industry, Initial Completeness Assessments for Type II API DMFs Under GDUFA, Draft Guidance (October 2012).

On Oct. 1, 2012, the European Medicines Agency announced publication of the “EURD list,” a list of European Union reference dates and frequency of submission of periodic safety update reports. The EURD list includes active substances and combinations of active substances in drugs that are subject to different marketing authorizations.