PharmTech News

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

FDA Food Center Reorg Puts Field Inspections in Limbo 

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided. 

Bioequivalence for Immediate-Release Solid Oral Dosage Forms 

Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris. 

Gerresheimer Presents New Clinical Trial Kit at Pharmapack

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

FDA Resumes In-Person Meetings with Industry … Sort Of

Pharmapack Europe experts expect smaller and medium European packaging companies to grow or be acquired.

Pharmapack Experts Predict Increased Packaging Consolidations in 2023

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

FDA Seeks to Simplify COVID-19 Vaccination Program

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.

FDA Releases Research Roadmap for Biosimilars Pilot Program

deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.

Amgen, Illumina, and Nashville Biosciences Announce Genome Sequencing Agreement

The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.

USPTO Issues Notice of Allowance for Zika Vaccine Patent 

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

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