19
Dec
Pre-Launch Activities Importation Request Image

Pre-Launch Activities Importation Request (PLAIR) Q&A Document Published by FDA

The Q&A document addresses a number of frequently asked questions about the Pre-Launch Activities Importation Request (PLAIR) process, and when you can or cannot use a PLAIR for importing unapproved drug product into the United States.  Quite interestingly, there are quite a few answers of “no” to the FAQs, which likely demonstrates that firms have […]

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04
Dec
Novel Photo

Novel Excipients – FDA Evaluates a Novel Program

Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect.  A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”.  Since the beginning of time, the Agency […]

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07
Nov
Gottlieb Tells Attendees at GRx-Biosims Image

Gottlieb Tells Attendees at GRx-Biosims Conference About His Term as Commissioner

Dr. Scott Gottlieb is back in the private sector and took the time to give the attendees at the AAM conference a brief overview of his experience as Commissioner.  Dr. Gottlieb spoke about the creation of the Competition Action Plan which addressed action on the following issues: Gaming the system through REMS and restricted distribution […]

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06
Nov
Global Regulatory Harmonization for Biosimilars Image

Global Regulatory Harmonization for Biosimilars

The reinvention of the AAM’s Fall conference from The Fall Technical Conference to the GRx + Biosimilars Conference continues to be a success.  This year’s meeting included a very stimulating and informative agenda pertinent to generic drugs and biosimilar products. On Monday morning, Suzette Kox, MSc, Pharm. Sec’y. Int’l. Generic and Biosimilar Medicines Association (IGBA) […]

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04
Nov
Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

AAM GRx-Biosims Meeting Day One Morning Highlights

The GRx-Biosims 2019 meeting started off with a meditation and stretching exercise; after that, we had to put our minds to work and begin exercising out neurons.  Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs, provided an update on generic drug activity, action plans, and biosimilars.  Key points and highlights were: Record breaking […]

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30
Oct
Drug Shortages Report Provides Look Forward Image

Drug Shortages Report Provides Look Forward

Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem.  Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy.  There has even been one firm created […]

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23
Oct

Have Postmarketing Study Requirements? You May Want to Read This!

FDA published a revised draft guidance titled Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.  If you have any post approval study requirements for any of your products, you should pay close attention to this document. In describing the document, the Agency says: “This […]

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22
Oct
Document Issued for Manufacturing Facility Information Image

Q&A Document Issued for Manufacturing Facility Information

The FDA released a final Q&A document titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers” that provides answers to some of the most frequently asked and problematic questions raised by incomplete manufacturing, testing, packaging, etc. The document provides specific guidance on what, where, and how to list such […]

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