Articles by Maribel Rios - Pharmaceutical Technology

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Articles by Maribel Rios

USP <1117> "Microbial Best Laboratory Practices": An Interview with Scott Sutton

Scott Sutton discusses the current state of USP 91117: and USP's plans for future revisions.
Nov 1, 2008

Scott Sutton discusses the current state of USP ‹1117› and USP's plans for future revisions.

FDA Awards NIPTE $1.19 M for QbD Guidance Project

Oct 30, 2008

The US Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE), a not-for-profit organization comprising 11 universities, a $1.19 million contract to develop quality by design (QbD) guidance elements for design space and scale-up of unit operations.

SPL Now "Only Acceptable" Format for CBER Original Submissions

Oct 15, 2008

According to a July 11, 2008 memorandum posted by the Center for Biologics Evaluation and Research, starting Oct. 15, Health Level 7 structured product labeling in XML (extensible markup language) will be the only acceptable presentation in electronic format for the submission of content of labeling that CBER can process, review, and archive.

Lilly to Acquire ImClone for $6.5 billion

Oct 9, 2008

Under a definitive merger agreement, Eli Lilly and Company will acquire ImClone Systems, Inc. (New York) in a cash tender offer of approximately $6.5 billion.

WirelessHART Gains IEC Approval

Oct 2, 2008

The International Electrotechnical Commission (IEC) has approved HART 7.1, the WirelessHART Communication Specification, as a Publicly Available Specification (IEC/PAS 62591Ed.1). WirelessHART is the first industrial wireless communication technology to achieve this level of approval.

Wyeth Prepares for Supreme Court Preemption Case

Sep 25, 2008

On November 3, the US Supreme Court will hear the case of Wyeth v. Levine, in which the drug company has challenged the ruling of a Vermont Supreme Court decision to award Diana Levine $6.8 million.

Nano "Ships" Designed for Drug Delivery

Sep 18, 2008

Researchers from the University of California San Diego, UC  Santa Barbara, and MIT have developed nanometer-sized hybrid structures carrying anti-cancer drugs and quantum dot imaging agents.

FDA Takes "First Step" in Modernizing CGMPs

Sep 11, 2008

FDA has issued a Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals."

USP Revises Potency Spec for Levothyroxine Sodium Tablets

Sep 4, 2008

USP announced an interim revision to its monograph for levothyroxine sodium tablets, which will become official in USP 32-NF 27.

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Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
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