Drugs
The FDA Oncology Center of Excellence and the LUNGevity Foundation have launched a multi-year longitudinal study to understand the lung cancer patient experience, irrespective of diagnosis (stage/histology), outside of the clinical setting. Project PEER (Understanding the Lung Cancer Patient Experience in the Real-World Setting) seeks to systematically
Biologics
Three law professors from different U.S. universities are joining the chorus of those expressing concern that FDA is under too much political pressure to make positive decisions on products to help resolve the Covid-19 pandemic. In a piece distributed online to be used as an op-ed, the
Drugs
Although Stericycle predicted a drop in product recalls during the Covid-19 shutdown of the U.S. economy that started at the end of the first quarter, recalls continued at their typical level, according to the company’s second-quarter report. The report section on medical devices says those companies
Devices
FDA has approved a Med-EL USA PMA supplement for the Rondo 3 Audio Processor for use with its Synchrony Cochlear Implant System. The company says the Rondo 3 offers wireless streaming, wireless charging with a rechargeable battery that lasts up to 24 hours, and compatibility with all hearing aids
FDA Policy/General
Federal Register notice: FDA has announced a 10/22 Patient Engagement Advisory Committee meeting. Panel members are scheduled to discuss artificial intelligence and machine learning in medical devices, particularly the composition of the datasets on which the software “learns”, components of the device information shared with patients, and factors that
Drugs
FDA has posted final determinations reached in July for three of the nine open drug efficacy study implementation (DESI) proceedings that look at the effectiveness of drugs that had been approved only for safety between 1938 and 1962. The post shows final determinations for pentaerythritol tetranitrate; peripheral vasodilators, Vasodilan (isoxsuprine)
Drugs
FDA has issued a draft guidance, Evaluating Cancer Drugs in Patients with Central Nervous System Metastases, to give the agency’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER that are intended to support product labeling describing the antitumor activity in patients
Drugs
FDA has accepted for priority review an EMD Serono NDA for once-daily, orally-dosed tepotinib for treating adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (MEtex14) skipping, as detected by an FDA-approved test.
Drugs
Several stakeholders took advantage of an FDA 7/23 virtual public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA) to praise the way PDUFA has worked for the last 30 years and offer suggestions for improvements in the 2022 PDUFA 7 reauthorization agreement. Pharmaceutical Research and
Biologics
Former FDA commissioner Margaret Hamburg and her principal deputy commissioner Joshua Sharfstein are using a Washington Post op-ed to urge the agency to take a firm stance for science and against political pressure and stage managing of agency decisions. The two say President Trump’s 8/23 announcement of
Drugs
Ipsen says it is planning to submit an NDA for palovarotene and its use in treating patients with fibrodysplasia ossificans progressiva (FOP). The submission will be based on data from the MOVE trial, a multicenter Phase 3 study. Earlier, dosing in the trial was paused when futility criteria were met
Drugs
FDA says it will not object to certain manufacturers temporarily distributing rifampin containing 1-methyl-4-nitrosopiperazine (MNP) or rifapentine containing 1-cyclopentyl-4-nitrosopiperazine (CPNP) above the acceptable intake limits to avoid shortages while the companies work to reduce or eliminate the impurities. An agency drug safety statement says
FDA Policy/General
[Report by Jim Dickinson and David McFarland] FDA commissioner Stephen Hahn’s controversial remarks exaggerating the efficacy of convalescent plasma for Covid-19 at an 8/23 White House press conference has touched off a wider examination of those advising (or directing?) him with his communications efforts. The 8/23
Drugs
FDA says it is removing a Boxed Warning about amputation risk on Janssen’s diabetes drug canagliflozin’s (Invokana, Invokamet, Invokamet XR) prescribing information. The agency required the warning in 2017 based on its assessment that the risk of amputations was very serious when considering canagliflozin’s benefit. “Subsequent FDA
Biologics
CBER has issued an update to its guidance agenda for calendar year 2020. The updated agenda shows guidances the Center plans to issue under four categories: Blood and Blood Components (14 guidances); Tissues and Advanced Therapies (10 guidances); Vaccines (one guidance); and Other (three guidances).
Drugs
CDER has issued a Manual of Policy and Procedures (MAPP), Transfer of Ownership, detailing how the Orange Book staff in the Office of Generic Drugs (OGD) will process requests submitted by former and new owners of drug applications to transfer drug application ownership. The MAPP says OGD is responsible for
Drugs
A 1/8-1/23 FDA inspection at Custom Nutraceuticals, Commack, NY, found significant violations of current good manufacturing practice regulations for dietary supplements, rendering the firm’s products to be adulterated. An 8/6 Warning Letter says the agency has not received a response from the firm concerning the
Drugs
FDA has approved Recordati Rare Diseases’ Cystadrops (cysteamine ophthalmic solution) 0.37%, a viscous eye drop solution that depletes corneal cystine crystal deposits in people living with cystinosis. The company says that Cystadrops demonstrated a significant reduction in cystine crystal deposits in the cornea of the eye and is the
Drugs
Dusa Pharmaceuticals, a Sun Pharmaceutical subsidiary, has agreed to pay $20.75 million to the U.S. to resolve allegations raised in a whistleblower lawsuit that it caused doctors to submit false claims to Medicare and the Federal Employee Health Benefit Program by knowingly promoting an administration process for the
FDA Policy/General
Federal Register notice: FDA has announced a 9/10 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. Panel members are scheduled to discuss required postmarketing studies that evaluated the effect of Purdue Pharma’s reformulation of Oxycontin (oxycodone
Devices
Smiths Medical has recalled specific software versions used with its Medfusion 3500 and 4000 Syringe Pumps because of an error that may lead to fluid/medication over delivery or under delivery. A recall notice says the delivery errors can occur if the following specific sequence of events occur: a bolus
Biologics
The three Democratic leaders of the House Energy and Commerce Committee have written to FDA commissioner Stephen Hahn seeking assurance that science and the protection of public health will drive agency decisions to authorize or approve a Covid-19 vaccine, and not political expedience. The 8/24 letter was sent