May 2019

30
May
pills and capsules

FR Notice Shows FDA Eager to Entertain/Require Packaging Options for Opioid Containing Products

In today’s prepublication of the Federal Register Notice entitled Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain (here), the Agency is opening a docket to receive comments on a requirement to blister package certain commonly prescribed opioid products in an effort to reduce the potential for over dispensing quantities […]

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29
May
Medicines Europe Conference

Frances Zipp of Lachman Consultants to be Featured Speaker at Annual Medicines for Europe Conference

(Westbury, NY – May 2019) Lachman Consultant Services, Inc. (“Lachman Consultants”), a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide, will be participating as a Conference Sponsor at the 25th annual Medicines for Europe and IGBA Conference. Entitled “Committing to Global Health – Balancing Access and Sustainability,” this […]

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28
May

USP Chapter <197> Spectroscopy Identification Tests – Controlling Your Identities!

This post was co-authored by Thu Truong, J.D., Senior Associate, Science and Technology Group, and Ron George, Ph.D, Director, Science and Technology Group Prior to USP 42 – NF 37 (effective April 30, 2019), USP Chapter <197>, Spectroscopy Identification Tests, stated, “The IR absorption spectrum of a substance, compared with that obtained concomitantly for the […]

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28
May

The Numbers Provide Proof of CGT Program

A podcast/article written by LCDR Rinku Patel, Pharm.D., Patent & Exclusivity Team, Office of Generic Drugs Policy, provides a description of the Competitive Generic Therapies program (which we have described previously here and here). Since we have covered the program in detail and there is an FDA draft Guidance available (here), we will not go […]

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28
May

The Treasure Map to Biosimilarity Just Got More Granular

The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced. The increased level of detail and wider breadth of topics gives a […]

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28
May

USP Chapter Spectroscopy Identification Tests – Controlling Your Identities!

This post was co-authored by Thu Truong, J.D., Senior Associate, Science and Technology Group, and Ron George, Ph.D, Director, Science and Technology Group Prior to USP 42 – NF 37 (effective April 30, 2019), USP Chapter <197>, Spectroscopy Identification Tests, stated, “The IR absorption spectrum of a substance, compared with that obtained concomitantly for the […]

Read More
24
May

The Treasure Map to Biosimilarity Just Got More Granular

The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced.  The increased level of detail and wider breadth of topics gives a […]

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