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FDA Proposes Distinct Naming Suffixes For Biosimilars, Biologics

FDA proposes to add suffixes to the nonproprietary names of both biosimilars and the brand biologics they reference, according to a long-awaited draft guidance on biosimilar naming that the agency released Thursday (Aug. 27).

HRSA Issues Wide-Ranging 340B Guidance

The Health Resources and Services Administration proposed Thursday (Aug. 27) long-awaited guidance on the 340B drug discount program, clarifying the definition of a 340B patient, contract pharmacy arrangements, audit procedures and avoiding duplicate discounts, among other provisions.

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Stakeholders advised FDA Monday (Aug. 24) to start small, and expand and evolve its requests for quality metric data from drug manufacturers as it learns whether specific data are effective at measuring quality at manufacturing facilities.

FDA approved Thursday (Aug. 27) the second PCSK9 inhibitor, a new class of LDL cholesterol-lowering medications, for use in patients who are unable to control their cholesterol levels with the current treatment options.

The number of accountable care organizations is increasing and they are saving Medicare more money, according to a CMS release, but providers say the average savings per ACO declined, and they offered a tepid response to results from ACO performance in 2014 that CMS released Tuesday (Aug. 25).

The Federal Trade Commission criticized FDA's regulatory oversight of homeopathic products as lax, arguing FDA’s policies are at odds with FTC’s more robust requirements for advertising claims on labels and could be a detriment to consumers.

About two dozen lawmakers have signed a letter urging CMS to drop two proposals that would cut pay for home health services, according to a spokesperson for Rep. Greg Walden (R-OR).

Sally Howard, FDA senior advisor to the commissioner and acting chief of staff, is leaving FDA at the end of September, according to an internal memo dated Wednesday (Aug. 26).

The so-called crosswalk bill that the House Ways & Means Committee is working on over recess could set the stage for combining Medicare Part A and Part B, hospital lobbyists said.

Home health providers are disappointed with the home health face-to-face encounter electronic clinical template CMS recently released for public comment, and some say it brings back the controversial physician narrative requirement in a new form.