Articles Tagged with ''FDA''

CMS DATA-RETENTION RULE EXTENDED TO 10 YEARS

In order for law enforcement officials to have access to older drugmaker records, the Centers for Medicare & Medicaid Services (CMS) has extended recordkeeping requirements for Medicaid-covered drugs from three years to a full decade.

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BIO CALLS FOR ESUBMISSIONS GUIDANCE FOR PROMO MATERIALS

The Biotechnology Industry Organization (BIO) wants the FDA to exclude promotional materials from its draft guidance on electronic submissions and develop separate guidance for advertising information that acknowledges the huge difference between ads and regulatory submissions.

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FDA WARNS XCEL ABOUT SALES INFORMATION FOR MIGRAINE DRUGS

Xcel Pharmaceuticals’ promotional materials for two migraine products omit risk information, make misleading comparative claims about safety and include unsubstantiated efficacy and indication claims, according to a letter from the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC).

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UNDISTRIBUTED REPROCESSED BATCH DATA NOT NEEDED

Drug companies do not have to include stability data on undistributed reprocessed batches that are not typical of batches produced by the approved manufacturing process in annual reports to the FDA, according to the Division of Manufacturing and Product Quality (DMPQ).

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PAIR OF GUIDANCES TO HARMONIZE STORED DRUG STABILITY TESTING

The FDA has revised storage stability testing of new drug substances and products, and products packaged in semipermeable containers, to accommodate climates that have higher humidity, the agency announced in a pair of revised guidances that went into effect in late November.

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