21:03 , Aug 13, 2018 |  BC Extra  |  Company News

Management tracks: FDA, Allergan

Patrick Frey will depart as chief of staff in FDA’s Office of New Drugs (OND) on Aug. 24 to become director of global regulatory policy and R&D at Amgen Inc. (NASDAQ:AMGN). Khushboo Sharma becomes OND’s...
17:25 , Jun 2, 2018 |  BioCentury  |  Politics, Policy & Law

Getting flatter

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, brought the center’s entire staff of about 5,000 people together in the agency’s Great Room on June 1 for a town hall meeting to...
23:46 , May 16, 2018 |  BC Extra  |  Politics & Policy

CMS initiates national coverage analysis of CAR T therapies

CMS began a national coverage analysis Wednesday to review the use of CAR T cell therapies to treat cancer. An NCA is the first step in the path to developing a National Coverage Decision that would...
00:25 , May 12, 2018 |  BioCentury  |  Politics, Policy & Law

Getting reorganized

FDA is reorganizing the Office of New Drugs in its Center for Drug Evaluation and Research, seeking to make review oversight more consistent while encouraging senior staff to become thought leaders. The changes at OND...
20:53 , Apr 25, 2018 |  BC Extra  |  Politics & Policy

CMS proposes new hospital reimbursement rate for CAR Ts

CMS has proposed to increase the rate at which it reimburses hospitals for ancillary costs associated with hospital stays for CAR T therapies. In an April 24 memo on its proposed FY19 Medicare hospital inpatient prospective...
20:22 , Nov 3, 2017 |  BioCentury  |  Regulation

Frame work

A little over four years into its implementation, FDA’s structured benefit-risk framework appears to be meeting its objectives of creating transparency into its approval decisions. The agency began to incorporate the framework templates into its reviews...
19:33 , Apr 13, 2017 |  BC Extra  |  Politics & Policy

FDA hiring freeze lifted, thaw uncertain

The Trump administration has replaced its hiring freeze with a plan intended to reduce the size of the federal workforce. An April 12 memo from Office of Management and Budget Director Mick Mulvaney instructs federal...
01:39 , Feb 18, 2017 |  BioCentury  |  Politics, Policy & Law

Hurry up and wait at FDA

President Donald Trump has shown more interest in FDA than most recent presidents, prompting speculation in Washington that he plans to rapidly appoint an activist commissioner. Trump fueled the rumors when he told pharma CEOs...
00:04 , Feb 10, 2017 |  BC Extra  |  Politics & Policy

HHS memo partly thaws hiring freeze

An internal HHS memo identifies categories of positions that are exempt from the Trump administration’s hiring freeze, including some FDA positions related to medical product oversight and reviews. FDA jobs related to public health safety and...
22:16 , Feb 3, 2017 |  BC Extra  |  Politics & Policy

Regulatory order applies to some guidances

FDA guidance documents and other “interpretive” documents may be subject to an executive order on reducing the costs of regulation, according to guidance provided to federal agencies Thursday. The order requires agencies to eliminate two regulations...