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Home » Topics » Pharmaceuticals » GMPs

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ANDA Sponsors’ Tablets/Capsules Should Hew Close to RLD in Size, Shape

December 13, 2013
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More

Roche Passes EMA Probe Into Safety Reporting Deficiencies

December 11, 2013
The European Medicines Agency has concluded a review of lax adverse event reporting at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. Read More

OTC Drugmaker Warned for Contaminated Water Supplies

December 10, 2013
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More
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Jubilant Receives FDA Warning Letter for Quality Deviations at Spokane Plant

December 10, 2013
The FDA has handed Jubilant HollisterStier a warning letter for quality shortcomings at its Spokane, Wash., sterile drug manufacturing facility. Read More

FDA Form 483 to Biogen Idec Cites Supplier Quality Management Issues

December 9, 2013
The FDA issued a Form 483 to Biogen Idec that cites a weakness in the way the company manages suppliers, highlighting the difficulties drugmakers continue to have with supplier quality issues. Read More

FDA Office of Generic Drugs Elevated to ‘Super Office’

December 9, 2013
HHS has approved the overhaul of the FDA's Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More

FDA to Consider Quality Metric Rankings at Request of Industry

December 9, 2013
The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More

Chinese Authorities Agree to FDA Inspection Expansion

December 6, 2013
Chinese officials have cleared the way for the FDA to station 10 additional drug and device investigators in China. Read More

Woodcock to Lead Planned Pharmaceutical Quality Super Office

December 6, 2013
CDER Director Janet Woodcock has decided to head the FDA’s new Office of Pharmaceutical Quality (OPQ) herself until it gets off the ground. The new office is planned as a “super office” that will oversee manufacturing quality throughout a drug’s lifecycle. Read More

FDA Wants Wockhardt Management Audited in Quality Data Probe

December 6, 2013
The FDA wants Wockhardt to investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift an import ban it slapped on the plant Nov. 26. Read More

FDA Developing Timeline for Track-and-Trace Implementation

December 6, 2013
With the new pharmaceutical track-and-trace law’s deadline for lot-level pedigrees looming, the FDA is still unclear about how it will regulate the complex requirement. Read More

Drugmakers Cite Confidentiality, Supply Chain Concerns With TGA Batch Release Guidance

December 5, 2013
Drugmakers are pushing back against Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration (TGA) to allow authorized persons to release batches without access to the product’s complete marketing application. Read More
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