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April 09, 2021

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Where N-Nitrosamine assessments for Drug Products meet Extractable / Leachable Qualifications for Pharmaceutical Primary Packaging

Recently there have been a number of drug product recalls due to the unexpected presence of N-Nitrosamines. While in most of those cases, N-Nitrosamine formation occurred at the level of the drug substance synthesis and stability, it is well known and documented that some materials, used in primary packaging can also be a source for N-Nitrosamine contamination of the packaged drug product (e.g. older grade elastomers and nitrocellulose laminated blister foils).

	Industry News

ImmunoPrecise Launches TATX-112 Candidate Antibody Program, for the Treatment of Cancer and Alzheimer’s Disease
Potential to Treat Parkinson’s and Other Neurodegenerative Diseases read more »

Mologic’s COVID-19 Rapid Antigen Self-Test Selected by NIH for RADx Initiative Funding
Mologic today announced its rapid antigen self-test for COVID-19 has been selected by the Rapid ... read more »

Acadia Pharmaceuticals Receives Complete Response Letter from U.S. FDA for Supplemental New Drug Application for Pimavanserin for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis
Acadia Pharmaceuticals Inc. today announced that the Company has received a Complete Response Letter... read more »

	Infographic

Preparing for the Worst-Case Scenario
A disaster can come in many forms and strike without notice. Smart labs plan in advance and formulate a lab continuity plan to ensure the shortest ... read more »

	Featured Articles

Software Under the Regulatory Microscope: The Current and Future State of Enforcement for Regulated Computer “Software,” as a term in the regulated life sciences industry, has a wide variety of definitions and uses. For example, software can be a stand- alone... read more »

Understanding FDA’s CSA Guidance in the Context of Current Regulations and GAMP® Computer Software Assurance (CSA) is a Case for Quality initiative that arose when computer systems validation was identified as a barrier to ... read more »

	Featured Whitepaper

White paper: Making the Switch to In-House Mycoplasma Testing
Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines state that recombinant bulk harvest must be tested ... read more »

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