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Gottlieb's FDA

June 05, 2018 | Daily News

In a move opposed by genetics professionals, FDA published a final order Friday (6/1) that put genetic health risk assessment systems on a list of Class II medical devices exempted from premarket notification 510(k) requirements, subject to certain limitations.

June 04, 2018 | Daily News

FDA announced Monday (June 4) evening approval of the first biosimilar to Neulasta (pegfilgrastim), which reduces the chance of infection for cancer patients undergoing chemotherapy.

June 04, 2018 | Daily News

FDA's evolving plan to significantly reorganize its Office of New Drugs includes centralizing project management functions across the agency's 19 review divisions, enhancing information technology capabilities, establishing a unified post-market safety surveillance framework, and focusing on multidisciplinary teams assigned to new drug applications, FDA Commissioner Scott Gottlieb and drug center Director Janet Woodcock announced Monday (June 4).

June 04, 2018 | Daily News

Senate appropriators are calling on FDA to develop a framework to add information about co-prescribing opioids with naloxone to opioid labels and Risk Evaluation and Mitigation Strategies information.

June 01, 2018 | Daily News

FDA plans to assemble an internal group that will determine how the agency should move forward with implementing the newly enacted federal Right to Try law, a spokesperson for FDA told Inside Health Policy Friday (June 1).

June 01, 2018 | Daily News

FDA's decision to take a hands-off approach toward medical device servicing has left servicers and device makers at odds: Servicers praise the move, but device manufacturers are upset and say Congress must now step in to require at least some minimal level of federal oversight.

May 31, 2018 | Daily News

The architect of the new national Right to Try law is already taking FDA Commissioner Scott Gottlieb to task over the agency’s planned implementation of that law.

May 31, 2018 | Daily News

FDA released long awaited guidance Thursday (May 31) outlining when the agency will waive the requirement that brands and generics share a single safety system, but those following the issue say FDA can only do so much without a change in statute.

May 31, 2018 | Daily News

FDA needs to tread carefully as it tackles the opioid epidemic by focusing on lowering misuse and abuse of prescription drugs to ensure it doesn't in turn cause people to turn to alternative substances and spark a new wave of addiction, FDA Commissioner Scott Gottlieb, drug center Director Janet Woodcock and Deputy Center Director for Regulatory Programs Douglas Throckmorton write in a New England Journal of Medicine article published Wednesday (May 30).

May 30, 2018 | Daily News

FDA is offering special incentives in its quest for medical and digital health device developers to submit proposals for “novel solutions” for detecting, treating and preventing addiction and for addressing diversion and treating pain, the agency said in a press announcement Wednesday (May 30).

May 29, 2018 | Daily News

FDA on Tuesday (May 29) opened a public docket to gather input on the benefits and risks to health associated with medical software functions excluded from the definition of a medical device in the 21st Century Cures Act.

May 24, 2018 | Daily News

The Senate Appropriations Committee on Thursday (May 24) voted to send to the Senate floor a fiscal 2019 FDA funding bill that appears to give the agency $163 million more than its current level but still less than requested by the administration, coming after House appropriators also agreed to hike FDA spending.

May 24, 2018 | Daily News

A new survey published by a precision medicine stakeholder group shows that, while most Americans have never heard of personalized or precision medicine, most had positive reactions when they were told what it was.

May 24, 2018 | Daily News

FDA Commissioner Scott Gottlieb is inviting internet stakeholders, including senior executives of major search engines, social media platforms, domain names registries and online marketplaces, to an opioid summit on June 27 to discuss ways to reduce illegal online opioid sales.

May 23, 2018 | Daily News

FDA commissioner Scott Gottlieb announced Tuesday (May 22) that his agency will soon be releasing a suite of draft guidances outlining potential accelerated approval endpoints for certain gene therapy products, starting first with products that treat hemophilia.

May 22, 2018 | Daily News

A Senate Appropriations subcommittee on Tuesday (May 22) voted unanimously to send to the full committee a fiscal 2019 FDA funding bill that appears to give the agency $163 million more than its current level but still less than requested by the administration, coming after House appropriators also agreed to hike FDA spending.

May 22, 2018 | Daily News

The House of Representatives passed 250-169 Tuesday (May 22) the Right to Try bill cleared by the Senate last year, sending the bill to the president's desk despite earlier concerns, shared by FDA at the time, that the bill lacked adequate patient safety protections.

May 22, 2018 | Daily News

Device industry lawyers say a rule proposed by FDA May 15 to revamp how the agency classifies combination products, while including some beneficial changes, doesn't fix fundamental problems that make the process frustrating for industry.

May 22, 2018 | Daily News

Device industry lawyers say FDA Commissioner Scott Gottlieb’s recent announcement of a data science incubator could lead to creation of large public databases of clinical evidence that genetic test developers could use to support clinical claims for their products.

May 21, 2018 | Daily News

Academic researchers found FDA has approved precision medicines 1.7 years faster on average than nonprecision medicine and with substantially less premarket evidence, which they cautioned could expose patients to unknown risks and uncertain benefits.

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