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November 01, 2011
June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.
October 20, 2011
Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers in solid oral dosage forms as an anticounterfeiting strategy.
October 02, 2011
Letting contamination build up can cause multiple headaches.
September 29, 2011
FDA has published a guidance on Marketed Unapproved Drugs-Compliance Policy Guide, which describes the agency's enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review.
FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds or reductions in prescription drug user fees.
September 02, 2011
Being aware of a forthcoming inspection or how a product was made can make a huge difference.
September 01, 2011
The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.
FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.
EMA announced that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011.
August 18, 2011
Since China's State Food and Drug Administration revised its GMPs last year, the agency has been making other improvements as well to improve the quality of its pharmaceutical manufacturing industry.