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Gottlieb's FDA

December 19, 2018 | Daily News

FDA’s framework for real-world evidence, released Dec. 6, illustrates the agency’s commitment to working with outside groups to expand the use of RWE and real-world data (RWD) in drug approvals and labeling, experts say.

December 19, 2018 | Daily News

Four device industry lawyers said the de novo rule proposed by FDA Dec. 4 could discourage product developers from entering the de novo pathway by making the route resemble the beefier premarket approval (PMA) process, which is typically reserved for higher-risk devices.

December 18, 2018 | Daily News

FDA announced two actions Tuesday (Dec. 18) aimed at encouraging industry to take advantage of two accelerated review and development pathways for new devices.

December 18, 2018 | Daily News

Surgeon General Jerome Adams issued an advisory on Tuesday (Dec. 18) warning about the dangers of e-cigarettes and urging parents, teachers, health care professionals, and state and local governments to apply known effective strategies to help prevent kids from using e-cigarettes.

December 18, 2018 | Daily News

A medical device industry lawyer said a recent report issued by FDA on digital health tools reassures stakeholders that the agency will not regulate five categories of software which Congress deemed safe when it passed the 21st Century Cures Act in 2016.

December 17, 2018 | Daily News

Early next year, Amy Abernethy of health care technology service company Flatiron Health will replace FDA’s Rachel Sherman as principal deputy commissioner, FDA Commissioner Scott Gottlieb announced in a memo sent to FDA staff on Monday (Dec. 17).

December 13, 2018 | Daily News

FDA on Thursday (Dec. 13) scrapped a controversial generic drug labeling proposal that would have allowed generic drug makers to update their drug labels with new information independent of labeling changes to the brand reference product.

December 13, 2018 | Daily News

A medical device industry lawyer says a newly unveiled FDA final rule on medical device classification and reclassification improves on the 2014 proposed rule, and it could indicate the agency intends to reclassify more devices as it moves to update its 510(k) process.

December 13, 2018 |

The Congressional Budget Office’s Dec. 7 publication of its cost estimate for the Senate’s over-the-counter monograph reform bill bolstered stakeholders’ hopes that the bill might pass the upper chamber before the end of the lame-duck session.

December 13, 2018 | Daily News

The Congressional Budget Office’s Dec. 7 publication of its cost estimate for the Senate’s over-the-counter monograph reform bill bolstered stakeholders’ hopes that the bill might pass the upper chamber before the end of the lame-duck session.

December 12, 2018 | Daily News

Heading into 2019, FDA plans to step up pharmaceutical enforcement and improve its inspection assessments using digital tools, FDA Commissioner Scott Gottlieb said Wednesday (Dec. 12).

December 12, 2018 | Daily News

FDA issued final guidance intended to clarify the role data integrity plays in current good manufacturing practices (CGMP) for drugs and to promote partnerships between FDA and its international regulatory counterparts on best practices on data security to help manufacturers advance their own compliance policies, FDA Commissioner Scott Gottlieb said Wednesday (Dec. 12).

December 12, 2018 | Daily News

FDA Commissioner Scott Gottlieb announced his agency will be discussing how to crack down on bad actors within the dietary supplement industry, including forming a working group to analyze how FDA could improve its oversight, reexamining the agency’s operating procedures, and potentially asking Congress for new authority in the space.

December 11, 2018 | Daily News

FDA announced Tuesday (Dec. 11) in new guidance documents that when insulin is reclassified from a drug to a biologic in 2020, it will not qualify for the 12-year exclusivity that new biologics receive.

December 11, 2018 | Daily News

FDA on Tuesday (Dec. 11) issued a proposed rule and a batch of guidance documents aimed at spurring biologics competition by bringing more biosimilars to market.

December 10, 2018 | Daily News

FDA released new draft guidance on Monday (Dec. 10) that agency head Scott Gottlieb and Deputy Commissioner Anna Abram say will make it more feasible for compounding pharmacies to become outsourcing facilities and ensure those facilities maintain current good manufacturing practices (CGMP).

December 10, 2018 | Daily News

FDA issued the interim results of agency-mandated duodenoscope reprocessing studies to help inform hospitals and health care facilities of the need to carefully clean and properly maintain the devices, the agency said Monday (Dec. 10).

December 07, 2018 | Daily News

FDA’s Bob Temple, a drug center veteran of 46 years, will soon become senior advisor for the Office of New Drugs’ Immediate Office -- becoming the center’s point person on medical decisions that are controversial, complex or critical, center director Janet Woodcock said in an internal email on Friday (Dec. 7).

December 07, 2018 | Daily News

Industry lawyers expect more in vitro diagnostic test makers to apply for CLIA waivers thanks to newly issued FDA guidances that make the process less prescriptive and clarify that tests for which trained and untrained users get comparable results are entitled to a waiver.

December 07, 2018 | Daily News

Thirteen Democratic senators are urging FDA Commissioner Scott Gottlieb to take stronger steps to prevent and reduce youth use of e-cigarettes by including mint- and menthol-flavored e-cigarettes among the types of products that would require stricter age verification and sales practices.

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