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Differences in National Shipping Requirements Challenge International Pharma

Pharmaceutical companies are wrestling with how to address the differences in country-specific regulatory requirements for shipping of their products, particularly regarding the allowance for minor excursions from the labeled storage conditions....

“Stability Budget” to Assure Quality During Drug Distribution Proposed by PDA Task Force with ICH Adoption in Mind

A “stability budget” is being proposed by a PDA task force as a viable approach for industry in its efforts to fill an important gap in assuring the quality of pharmaceutical products through the full-length of their distribution process....

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....

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....

Uncertainties in Subvisible Particulates Need to Be Understood, FDA Tells Biotech CMC Strategy Forum

The uncertainties around subvisible particles (SVPs) may warrant their being controlled as a critical quality attribute, FDA Office of Biotechnology Products Division of Therapeutic Proteins (DTP) Deputy Director Barry Cherney stressed at a CASSS/FDA CMC Strategy Forum in Washington, D.C in January....

Immunogenic Potential of Aggregates Affirmed at Biotech CMC Forum

The clear potential for aggregates of subvisible particles (SVPs) to cause immunogenic responses in both animals and humans was affirmed at the biotech “CMC Strategy Forum” held in Washington, DC, in mid-January.

ASEAN Effort Progressing on CMC/GMP Harmonization, But Differences Remain

An analysis of the CMC/GMP regulatory framework among the Association of South East Asian Nations (ASEAN) shows significant progress in moving toward a more cohesive and harmonized approach, although differences remain in individual country requirements and procedures....

FDA, USP and CHPA Team Up to Address OTC Drug Impurity Problems

A committee comprised of experts representing FDA, the US Pharmacopeia (USP) and the Consumer Healthcare Products Association (CHPA) is considering how to strengthen the control of impurities in over-the-counter (OTC) products....

FDA Draft Guidance Promotes the Use of QbD to Help Solve Residual Drug Problems in Transdermal Delivery Systems

FDA’s new draft guidance on transdermal and related drug delivery systems discusses the agency’s concerns with the residual drug left in the delivery systems after the intended use period and recommends manufacturers use quality-by-design (QbD) principles to minimize the problem for both new and existing products....

New Oral Formulation Approaches Are Accelerating Product Movement Into the Clinic

The use of micro-dosing in clinical formulations is increasing as firms wrestle with how to get their new oral drug products to the clinic as quickly as possible with the fewest regulatory hurdles....
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