Joanne Gray

Joanne Gray

Goodwin Procter LLP

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FDA Holds Public Hearing On Proposed Label Change Rule

On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more

3/31/2015 - FDA Generic Drugs Labeling Pharmaceutical Manufacturers Public Meetings

Major Donut Chain Reformulates Powdered Sugar Due to Concerns Over Claimed Nanomaterials

A major donut chain has reformulated the powdered sugar used in its donut products to address investor and consumer activist group concerns over the alleged presence of nanomaterials. The move secured the withdrawal of a...more

3/11/2015

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

2/23/2015 - ANDA Drug Manufacturers FDA Generic Drugs Labeling Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Product Labels

REsource - Winter 2013/2014

In This Issue: Bringing Non-U.S. Capital Into (and Back Out of) U.S. Real Estate; A Wider Play of Shale: A Hydraulic Fracturing Primer; California Clears Way for Pollution Clean-Up with AB 440; and Which Way is the...more

1/13/2014 - Contaminated Properties Foreign Investment Fracking Natural Gas Oil & Gas Pollution Control Real Estate Market REIT

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