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Gottlieb's FDA

November 17, 2017 | Daily News

Generic stakeholders are clashing with FDA over what most thought were completed Generic Drug User Fee Amendments (GDUFA II) negotiations, namely the steps sponsors must take to be eligible for priority review.

November 17, 2017 | Daily News

FDA issued long-awaited guidance answering industry questions about how to comply with its menu labeling rule, slated to go into effect May 7, 2018, but the industry noted it will exercise enforcement discretion for out-of-compliance companies to help them comply with the law.

November 17, 2017 | Daily News

FDA's recent alert on alleged health risks associated with the herbal product kratom is being challenged by the American Kratom Association, which is petitioning the agency under the Information Quality Act to set up a special advisory committee of independent experts to review the accuracy and integrity of the data underlying FDA's advisory, and to hold a public meeting on the product.

November 16, 2017 | Daily News

FDA has introduced a new risk-based framework, accompanied by two final guidances and two new draft guidances, for regulating regenerative medicines, the agency announced Thursday (Nov. 16).

November 06, 2017 | Daily News

FDA will work with the Department of Homeland Security and local authorities in Puerto Rico to help a subset of drug and device manufacturers to jump the line for getting back on the electrical grid, FDA Commissioner Scott Gottlieb announced Monday (Nov. 6) at an Association for Accessible Medicines conference.