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CDER Officials Shed Light on Forces Impacting Generic Injectable GMP Compliance and Drug Shortages

FDA’s current engagement with the GMP compliance problems in the generic injectable arena illustrates the tightrope the agency is walking in trying to protect patients against substandard, high-risk products, while at the same time trying to assure that they have access to the critical medicines they need...

Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States

The State of Massachusetts has closed three more compounding pharmacies in the wake of its ramping up of oversight of those making sterile injectables....

Congressional Hearings Expand Meningitis/NECC Probe; More Light Shed on Regulatory Gaps

The Congressional investigation into the fungal meningitis outbreak caused by contaminated injectable methylprednisolone acetate (MPA) made and distributed by the New England Compounding Center (NECC) continued to expand in depth and breadth with a pair of hearings held in the House and Senate, respectively, in mid-November....

FDA Inspection Findings of Sterile Practice Breeches at Ameridose Mirror Those at NECC

A resource-intensive investigation by FDA of Ameridose’s sterile manufacturing operations has found a markedly similar gap from acceptable practice to that agency investigators found at the New England Compounding Center (NECC) – the sister company to Ameridose responsible for the fungal meningitis outbreak....

Supply Chains and Customer Service Need Prompt Shoring Up, Veteran Pharma Exec Warns

A veteran pharma executive is sounding a warning call to industry that its current approach to supply chains, outsourcing and customer service needs to be overhauled quickly to address the disruptions causing drug shortages, advance operational excellence, and restore its reputation....

MHRA Publishes Inspection Findings Summary; EMA Discontinues Publication of “Top 40” list

At an “OOS Forum 2012” in mid-June in Prague, Czechoslovakia, sponsored by the European Compliance Academy (ECA) in cooperation with Europe’s QP Association, UK Medicines and Healthcare products Regulatory Agency (MHRA) GMP inspector Di Morris presented her agency’s top ten findings from GMP inspections between April 2011 and March 2012 (link provided below). MHRA’s annual […]

Former FDA Chief Counsels Examine the Shifting Sands of FDA Enforcement Policy

The dramatic decline in the number of product seizures was cited as one indicator of the shifting sands of FDA enforcement policy by a panel comprising several decades of former FDA chief counsels at the Food and Drug Law Institute (FDLI) annual meeting in late April in Washington, DC....

FDA Would Like 483 Responses to Also Address Investigator Concerns Expressed Verbally

FDA field compliance officials are recommending that concerns raised verbally during a GMP inspection be addressed in writing by the firm either in its response to a 483 or independently, whether or not a 483 is issued....

FDA GMP Compliance Spotlight Will Remain Centered on Conventional Aseptic Processing

FDA is putting industry on notice that conventional aseptic processing lines not employing isolators or restricted access barrier systems (RABS) will get heightened scrutiny from agency investigators and that a convincing justification will have to be provided for their ability to consistently produce sterile product....

Pakistani Supreme Court Orders Creation of National Drug Regulatory Authority

In early February, the Pakistani Supreme Court directed the federal government of Pakistan to establish a “Drug Regulatory Authority” within 10 days, after it was informed that five countries had banned the import of Pakistani medicines after the deaths of over 135 patients in Pakistan as a result of contaminated drugs, according to The News […]
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