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Archive for ‘March, 2011’

Risk-based Approach to Combination Products Advocated to Improve Communications with Regulators and Streamline Filing

A risk-based approach could clarify and simplify the regulatory pathway for combination products, Lilly CMC Regulatory Affairs Principle Consultant LeAnn Chambers maintained at a DIA CMC Workshop in February....
March 31, 2011 | Posted in CMC Review Policy, Combinations, Product Type Specific, The News in Depth, US/Canada | Read More »

Types of Drug/Device Combination Products in the EU Definition and Example EU Class Regulatory Approval Route Notified Body? Notes Type I Device intended to administer a drug;  e.g. a syringe marketed alone intended to be used to administer a drug Device Declaration of conformity by the manufacturer and attachment of CE symbol to [...]
March 30, 2011 | Posted in Uncategorized | Read More »

Year-End Filing Deadline Causing a Flurry of Activity for PET Drug Makers and Regulators

A December 12, 2011 filing deadline for new and abbreviated new drug applications (NDAs/ANDAs) for all positron emission tomography (PET) drugs currently in commercial clinical use is putting heat on manufacturers and FDA to address the outstanding quality regulatory issues for this unique and challenging class of high-tech injectable products....
March 27, 2011 | Posted in CMC Review Policy, PET, Product Type Specific, The News in Depth, US/Canada | Read More »

Recent PET Drug Inspection Findings Shed Light on Upcoming FDA Focal Points

Recent inspection findings at positron emission tomography (PET) drug manufacturing facilities regarding sterility assurance, testing, training and quality oversight provide insight into what FDA investigators will be looking for when inspecting these manufacturers – most for the first time....
March 27, 2011 | Posted in CMC Review Policy, Inspection Initiatives, PET, Product Type Specific, Product-type Specific, The News in Depth, US/Canada | Read More »

IPQ’s Monthly Update for February 2011 Now Available

IPQ’s coverage of CMC and GMP developments in the Asia Pacific region continues in the February Monthly Update with an analysis of South Korea’s quest to harmonize and keep pace with the advancing international pharmaceutical quality regulatory paradigm....
March 26, 2011 | Posted in The News in Depth | Read More »

IPQ Monthly Update — February 2011

The Monthly Update covering the key CMC and GMP developments in the US, Europe and internationally during February is now available.
March 24, 2011 | Posted in Current Issue, Issue Archive, Monthly Update | Read More »

Relationships, Communication Gaps for Atypical Actives Aired at PDA/FDA Workshop

The relationships and the communication gaps between ingredient producers, distributors, dosage form manufacturers and regulators when atypical actives are involved received a public airing at a workshop cosponsored by PDA and FDA in March in Bethesda, Maryland....
March 21, 2011 | Posted in CMC Review Policy, Excipient, Formulation, International, Product Type Specific, The News in Depth | Read More »

Insights from Atypical Actives Workshop Could Drive Needed Technical/Regulatory Guidance, Participants Affirm

The insights that emerged at a PDA/FDA workshop on atypical active ingredients could form the basis for guidance that would clarify the regulatory expectations involved and help close the existing communication gaps in the manufacturing and distribution chain....
March 21, 2011 | Posted in CMC Review Policy, Excipient, Formulation, International, Product Type Specific, The News in Depth | Read More »

McNeil Consent Decree Reflects Previous Big Pharma Injunctions Minus Disgorgement

The consent decree signed between McNeil and the U.S. Department of Justice on March 10 covering its Fort Washington, Lancaster and Las Piedras facilities contains the standard CGMP injunction provisions for independent expert consultant oversight and monetary penalties if the specified remediation timetables are not met. However, it does not include the large “disgorgement” fines characteristic of similar big pharma injunctions over the past decade....
March 14, 2011 | Posted in Consent Decrees, GMP Enforcement Activity, The News in Depth, US/Canada | Read More »

FDA Unapproved Drugs Initiative Orders Hundreds of Cough/Cold Products off the Market

FDA is taking another significant step in its unapproved drug enforcement initiative by ordering that hundreds of oral prescription (Rx) drugs used to treat coughs and colds be taken off the market....
March 9, 2011 | Posted in Inspection Initiatives, Oral, Product-type Specific, The News in Depth, US/Canada, Unapproved Drugs | Read More »
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