Articles by Maribel Rios - Pharmaceutical Technology

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Articles by Maribel Rios

Draft Guidance Issued for Influenza Drug Development

Feb 26, 2009

The US Food and Drug Administration has released a draft guidance for industry entitled Influenza: Developing Drugs for Treatment and/or Prophylaxis.

Court Rules No Link Between MMR Vaccine and Autism

Feb 19, 2009

After two years of hearings, more than 5000 pages of expert testimonies, and 939 medical articles, a special federal court ruled that there was little, if any, evidence to support the claim that substances in the measles, mumps, and rubella vaccine (including the use of thimerosal) had led to the autism of three children.

Congress Introduces FDA Globalization Act of 2009

Feb 12, 2009

Congressman John D. Dingell (D-MI) introduced HR 759, known as the Food and Drug Globalization Act of 2009, which would amend the Food, Drug, and Cosmetic Act to address food, drug, and device safety, including registration of producers of drugs and applicable fees, documentation for admissibility of drug imports, country of origin labeling, and the inspection of producers of drugs and active pharmaceutical ingredients (API).

USP Announces New Standards for Heparin and Glycerin

Feb 5, 2009

The US Pharmacopeial (USP) Convention has announced new standards for heparin and glycerin.

Illuminating Heavy Metals Testing

USP <231> Heavy Metals is transitioning toward the incorporation of modern quantitative technologies, but there is still much to be resolved.
Feb 2, 2009

USP <231> Heavy Metals is transitioning toward the incorporation of modern quantitative technologies, but there is still much to be resolved.

Physician Payments Sunshine Act Reintroduced for 2009

Jan 29, 2009

Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) have introduced S. 301, known as the Physician Payments Sunshine Act of 2009 to the 111th Congress.

Lilly Resolves Investigation of Marketing and Promotional Practices

Jan 22, 2009

Eli Lilly and Company has reached resolution regarding its previously reported government investigation into the company's US marketing and promotional practices for "Zyrexa" (olanzapine), an antipsychotic drug, thereby ending a government investigation started in 2004.

Federal Agencies Release Draft Guidance for Good Importer Practices

Jan 15, 2009

A draft guidance for industry titled "Good Importer Practices" has been released to provide importers guidance on the steps they can take to help ensure imported products comply with the relevant statues and regulations of the United States throughout a product's lifecycle.

NMR Approach May Speed Up Protein-Based Drug Development

Jan 8, 2009

Michigan State University researchers have discovered a technique for viewing whole cells to gain an understanding of protein inclusion bodies.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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