An Industry Commentary on Regulatory Issues–Microbiology

JE Moldenhauer - PDA Journal of Pharmaceutical Science and …, 2002 - journal.pda.org
An Industry Commentary on Regulatory Issues – Microbiology | PDA Journal of Pharmaceutical
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[CITATION][C] The regulatory obstacles hindering antibacterial development

E from Replidyne, US Colorado - Inpharma, 2007 - Springer
Pharmaceutical and biotechnology companies are finding it increasingly difficult to produce
antibacterials that will be approved by regulatory agencies and be profitable once they …

[HTML][HTML] The responsibility of the pharmaceutical industry

C Durrant - Clinical Microbiology and Infection, 2001 - Elsevier
The pharmaceutical industry plays an active role in policy surrounding the research,
discovery and development of new medicines. Along with this commitment, the …

[CITATION][C] Moving goalposts—regulatory oversight of antibacterial drugs

R Brenner, EJ Ellis-Grosse, R Echols - Nature biotechnology, 2006 - nature.com
Industry and other special advocacy groups have been vocal about the need for regulatory
reform to provide incentives for the industry to continue to develop antimicrobial compounds …

Fidelity to Science & Correct Scientific Vocabulary—Microbial Control Versus Contamination Control

EC Tidswell, R Tirumalai, D Hussong - PDA Journal of …, 2019 - journal.pda.org
More than at any other moment in our history, it is imperative that we maintain fidelity to
sound science and ensure the correct use of the associated scientific vocabulary. This is …

[PDF][PDF] Regulatory Status of Microbes as Antibiotics: An Overview

Y Soni, P Sangwan, N Sharma, P Ahirwar… - Glob. Acad. J. Pharm …, 2023 - gajrc.com
Regulatory affairs (RA) play crucial roles in the pharmaceutical industry because they are
concerned with the lifecycle of healthcare products, they offer strategic, tactical, and …

A Manufacturer's Perspective: Recent Challenges in Antibiotic Drug Approval

CH Burke, GM Levitt - FDLI Update, 2008 - HeinOnline
Due to the emergence of antimicrobial resistance, it is essential that we have access to a
number of antibiotics to treat microbial infections. If we were to rely on just a few drugs, the …

[PDF][PDF] Yin, yang and the biopharmaceutical industry

HI Miller - Journal of Commercial Biotechnology, 2003 - commercialbiotechnology.com
The historic decline of technology stocks over the past three years has seen the
biopharmaceutical sector ravaged more than most. Investors are realising that there are too …

Time for a change: addressing R&D and commercialization challenges for antibacterials

DJ Payne, LF Miller, D Findlay… - … Transactions of the …, 2015 - royalsocietypublishing.org
The antibacterial therapeutic area has been described as the perfect storm. Resistance is
increasing to the point that our hospitals encounter patients infected with untreatable …

[PDF][PDF] Antibiotic development and the changing role of the pharmaceutical industry

DL Monnet - International Journal of Risk & Safety in Medicine, 2005 - reactgroup.org
There is a complex relationship between the pharmaceutical industry and society. The
industry, patients, physicians, regulators and politicians are all driven by their own agendas …