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Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage

An early February letter from CDER Director Janet Woodcock to hospital infusion/admixture supplier PharMEDium Services puts compounders and the hospitals they serve on notice that the agency will expect compounded preparations to be linkable to the specific patient using them....

FDA Releases Final Guidance on PET Drug INDs

FDA has released a final guidance on Investigational New Drug (IND) Applications for Positron Emission Tomography (PET) Drugs that updates a draft released in February with only minor changes. The guidance summarizes the IND process for unapproved PET drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, […]

Sponsor/CMO Communication Gaps Will Have Negative Inspection Fallout, FDA Field Investigator Cautions

The lack of communication between sponsors and contract manufacturing organizations (CMOs) – particularly those located abroad – can make the FDA inspection process a difficult one and can jeopardize the compliance position of the CMO involved as well as the approval of the sponsor’s application, agency investigators are warning....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

SFDA Completed Ten GMP Inspections of Overseas Manufacturers in 2011

In 2011, China’s State Food and Drug Administration (SFDA) completed ten GMP inspections of firms in the US, the EU, South Korea and India that manufacture vaccines, APIs, biologics, and oral solid dosage forms and sell their products in China. The overseas inspections were announced last October (IPQ “The News in Depth” Nov. 10, 2011), […]

FDA Releases Final Guidance on PET Drug Media Fills; Application Filing Deadline Extended

FDA has finalized a guidance on positron emission tomography (PET) drug media fills that was released as a draft last September and has effectively extended the December 2011 deadline for PET drug application submissions until June....

Generic Injectable GMPs Again Prompt FDA Warning – APP Added to Non-compliance Watch List

Consumer complaint handling and failure investigation issues have placed another large generic injectable drug manufacturer, American Pharmaceutical Partners (APP), onto FDA’s GMP non-compliance watch list....

Growing Cooperation Between FDA and EMA Highlighted in Recent Ben Venue Inspections

The mutual focus of FDA and EMA on aseptic processing compliance at Ben Venue’s Bedford, Ohio plant – which has resulted in an EMA recommendation to recall three oncology drugs contract-manufactured by Ben Venue and the firm's decision to cease operations at the facility while the issues raised are being addressed – illustrates the increasing level of cooperation among international agencies in the GMP arena....

EDQM Publishes First Monthly Report on Certification of Substances

The European Directorate for the Quality of Medicines (EDQM) has published its first monthly report on the Certification of Substances Division (DCEP) The September report notes that the DCEP received 32 new certification (CEP) requests in September and approved 20.  It also received 122 revisions, including notifications and renewals, and suspended or withdrew five CEPs. […]

China’s SFDA Begins Inspections of Overseas Manufacturers

China’s State Food and Drug Administration (SFDA) is initiating inspections of pharmaceutical manufacturing facilities overseas that sell products in China as part of its ongoing effort to modernize and harmonize regulatory practices with international standards and ensure the quality and safety of medicines sold in its country.
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