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Comment Extension on cGMPs for Combination Products

The comment period on FDA’s draft guidance on cGMPs for combination products has been extended until April 23. The draft was issued in January (IPQ “News in Brief” January 27, 2015). The Regulatory Affairs Professional Society (RAPS) in conjunction with FDA held a workshop to discuss the new draft guidance and collect industry feedback on […]

Draft CGMP Requirements for Combination Products

In late January, FDA released a draft guidance on CGMP requirements for combination products. The guidance is organized into four main sections, covering: ● background ● general considerations for CGMP compliance ● specific information on 21 CFR 4.4(b), and ● applications for specific types of combination products. The guidance fleshes out the January 2013 final rule 21 CFR […]

FDA Issues New BA/BE Draft Guidance

An FDA draft guidance for establishing bioavailability/bioequivalence (BA/BE) was released in late March and is intended to replace the existing 2003 BA/BE guidance. The guidance details the methods most suitable and accurate for the determination of BA/BE, as required by FDA. An expanded section is included on in vitro studies and their applicability for different formulations. […]

Better Human Factors Analysis is Driving New Combination Product Technologies Designed to Reduce User Errors

Multi-sensory training tools and design features for auto-injectors, including audio instructions, are among the error-reduction technologies being driven by better human factors (HF) analysis in the drug/device combination product arena....

IPQ Monthly Update — April, 2013

The annual conference of the Food and Drug Law Institute (FDLI), held in downtown Washington in mid-April, again provided an important venue for FDA to deliver a “state of the agency” address on the key legal, legislative and regulatory developments during the previous year and what to expect in the year to come....

FDASIA Implementation and a Sharpened Focus on Quality Head Center for Drugs’ Agenda

The impact of the Food and Drug Administration Safety and Innovation Act (FDASIA) on the Center for Drug Evaluation and Research (CDER) is beginning to be felt as the center comes to grips with implementing the requirements of the Act and the organizational effort it will take to meet them....

FDA Draft Guidance on Syringe Connection Problems Reemphasizes Need for Early Agency/Sponsor Dialogue on Combo Products; Postapproval Change Guide Issued

A new draft guidance from FDA on glass syringe connection problems, which have been associated with serious adverse events and quality issues over the past few years, reemphasizes the need for early dialogue between combination product sponsors and the agency to avoid potential design and development pitfalls....

Better Glycosylation Understanding Would Further International Biotech Regulatory Convergence Efforts, CMC Strategy Forum Participants Agree

Regulators are highlighting a better understanding of protein glycosylation – its linkage to product safety and efficacy and what constitutes appropriate characterization – as an important element in developing a more internationally-aligned approach to regulating biotech products....

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....

FDA Expectations for Studying Human Factors in Pre-filled Syringes are Taking Shape

FDA is increasing its pressure on sponsors to conduct pre-market human factors (HF) studies for combination products, including pre-filled syringes, and industry is getting clearer on the agency’s expectations as more experience is gained....
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