The Regulatory Affairs Professionals Society (RAPS) is pleased to announce that US Food and Drug Administration (FDA) Commissioner Robert Califf, MD will speak at RAPS Convergence 2022, 11-13 September, in Phoenix, AZ at the Phoenix Convention Center.   After holding two years of virtual conferences, Convergence will commence its return to an in-person meeting with an opening plenary session where Califf will present on 11 September at 4:30 pm MDT. The commissioner w...

The US Food and Drug Administration (FDA) needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. Not doing so will continue to undermine the public’s trust in the agency, said a panel of former FDA commissioners and others at the Food and Drug Law Institute (FDLI) annual conference on Tuesday.   Califf ad...

Combatting misinformation about science and responding to the ongoing COVID-19 pandemic are the top priorities for Robert Califf as he retakes the helm of the US Food and Drug Administration (FDA).   Califf’s priorities were outlined in a 17 February memo to FDA staff, as well as on his new official Twitter feed ( @DrCaliff_FDA ). Califf was as confirmed as commissioner for the second time on 15 February by a narrow win in a 50-46 vote and sworn in two days later. Ca...

Three months after his nomination by President Joe Biden, and despite weeks of uncertainty over whether he could muster enough Republican votes to overcome Democratic defectors in a narrowly split Senate, Robert Califf was confirmed as commissioner of the US Food and Drug Administration (FDA) for the second time on Tuesday in a 50-46 vote.   The vote came after the confirmation cleared a procedural hurdle on Monday, in which five Republicans joined most Democrats in ...

Regulatory and industry experts agree that completing confirmatory studies quickly is essential to the success of the US Food and Drug Administration’s (FDA) accelerated approval program, with some suggesting that new legislation might be necessary to reliably get results from these trials in a timelier manner.   Robert Califf, head of clinical policy and strategy for Verily and Google Health and the Biden Administration’s nominee to be FDA commissioner, said a legisla...

Despite some rumbling about his ties to the pharmaceutical and tech industries, Robert Califf breezed through a two-hour nomination hearing on Tuesday for a second stint as commissioner of the US Food and Drug Administration (FDA).   Califf’s nomination by President Joe Biden last month came after a protracted period of speculation as to who would be chosen to lead FDA at an unprecedented time in the agency’s history. During the hearing, Califf laid out three overarchi...

Following in the tradition of recently departed US Food and Drug Administration (FDA) commissioners, Scott Gottlieb is joining the board of directors at Pfizer. In addition to his role on the Pfizer board, Gottlieb, an elected member of the National Academy of Medicine, is also resident fellow at the American Enterprise Institute and a partner at the venture capital firm New Enterprise Associates. Reactions to Gottlieb’s decision to join the Pfizer board ranged from ...

Generic versions of Teva's multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) have arrived, but a closer look at which competitor might win the coveted 180-day exclusivity reveals an unusual and complex situation. Back in January, a US District Court for the District of Delaware ruling invalidated all asserted claims  on Teva's patents on its 40 mg version of Copaxone, opening the door for generic competitors. Late Tuesday, Mylan  announce...

Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks and clinical trial designs of new drugs and medical devices sped to market without enough preliminary evidence that they are effective. In one of the articles, which evaluated the use of FDA’s accelerated approval pathway, questions were raised on the use of surrogate measures as outc...

Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories. The non-compliance report calls out the site, which manufactures and packages non-sterile capsules and tablets, for one critical deficiency related to the essential elements of its...

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach." Former commissioners Robert Califf, MD, Margaret  Hamburg, MD, Mark McClellan, MD, PhD and Andrew Von Eschenbach, MD, write that although in some shortage cases, importation of generic dru...

Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy. “Some argue that individuals and their physicians should be free to make these decisions without relying on FDA to make determinations about marketing approval. However, the complexity of the data as well as examples ...