Drugs
FDA has issued Merck a complete response letter on a supplemental BLA seeking to update the dosing frequency for Keytruda (pembrolizumab) to include a 400 mg dose infused over 30 minutes every six weeks for multiple indications. The submission is based on pharmacokinetic modeling and simulation data, Merck says, adding
Devices
ResMed has recalled its Stellar 100 and 150 Non-invasive and Invasive Ventilators due to a sound alarm failure. According to a recall notice, the alarm may fail to work if the device has a failed electronic part or if it is stored without AC power connected for more than
Drugs
FDA has sent Aurobindo Pharma an Establishment Inspection Report (EIR) for Unit 4 of the company’s general injectable formulation manufacturing facility on Pashamylaram, Hyderabad, India. A report on the Indian Web site Livemint says the company did not disclose details of the EIR in its regulatory filing. FDA inspected
Drugs
CDER Office of Generic Drugs (OGD) director Sally Choe says the organization gave final or tentative approval to more than 1,000 ANDAs in calendar year 2019. Writing in the OGD annual report, Choe says that while the numbers “indicate another accomplished year for the program, we know what truly
Devices
FDA says an Abbott Vascular 1/29 recall of specific lots of its NC Trek RX coronary dilation catheter and NC Traveler RX coronary dilation catheters is Class 1. The catheters were distributed between 8/2019 and 1/2020 and 13,891 devices were recalled in the U.S. An
Drugs
Rep. Kevin McCarthy (R-CA) and David Schweikert (R-AZ) are asking FDA to hold public workshops on the development of Valley Fever diagnostics, drugs, and biologics to inform the development of a guidance to help with approval of these and related products. In their letter, the two write that
Drugs
FDA has extended its review of Heron Therapeutics’ NDA for its HTX-011 for up to three months, resulting in a new PDUFA goal date of 6/26. The agency sent the company a 4/30/19 complete response letter relating to chemistry, manufacturing, and controls and to non-clinical
Drugs
The First Circuit Court of Appeals has sent back to a Massachusetts federal court a case in which purchasers of direct insulin glargine alleged that Sanofi artificially restricted competition in the market for insulin glargine by impermissibly extending its monopoly over such products. The appeals court reported that the purchasers
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: R-Garden, Redmond, WA (2/5): FDA inspected the company 8/2019 and cited serious GMP violations for its dietary supplements. For
Drugs
FDA has approved the switch of three prescription drugs to over-the-counter status for GlaxoSmithKline’s Voltaren (diclofenac sodium topical gel, 1%), Alcon’s Pataday (olopatadine HCl ophthalmic solution/drops, 0.1%) twice daily and Pataday (olopatadine HCl ophthalmic solution/drops, 0.2%) once daily. Voltaren is indicated for
Devices
FDA has cleared an Additive Implants 510(k) for the SureMAX-X Cervical Spacer, a 3D-printed titanium spinal surgery device designed to create uniform end plate coverage and optimize load distribution. The device’s roughened porous and convex shaped surface provides contact with the bony endplates, the company says.
Biologics
CBER has released its Guidance Agenda showing 21 topics the Center is considering for guidance development during calendar year 2020. The document says the list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued
Drugs
The Justice Department says Hector Kellum, a former senior executive at an unidentified New Jersey generic drug company, pleaded guilty 2/14 to his role in a conspiracy to fix prices, rig bids, and allocate customers for generic drugs. The New York Times identified Kellum’s former employer as Novartis’
FDA Policy/General
Federal Register notice: FDA has opened a docket to obtain data and information related to vaping products that are associated with recent lung injuries. This request for information responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the agency could
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Endorecherche’s Intrarosa (prasterone), indicated for treating moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. The regulatory review period is 3,381 days, which includes 2,983 days that
FDA Policy/General
Federal Register notice: FDA has announced a 3/10 public meeting entitled “Patient-Focused Drug Development for Stimulant Use Disorder.” The meeting seeks to obtain stakeholder perspectives on stimulant use disorder impacts and views on treatment approaches. To view the notice, click here.
Devices
Philips Respironics has recalled (Class 1) its Trilogy EVO Ventilator and Trilogy EVO Universal Ventilator due to a software defect. The devices measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with appropriate accessories. According to a recall notice, the software defect can cause “inoperative
Drugs
FDA says that a January enforcement operation conducted with the government of India stopped some 500 shipments of illicit and potentially dangerous unapproved prescription drugs and combination medical devices from reaching American consumers. An FDA statement says Operation Broadsword, the first bilateral enforcement operation conducted with India, targeted packages entering
Drugs
CDER has published the FY 2019 GDUFA Science and Research Report detailing “significant accomplishments in developing the scientific basis supporting new and revised guidances for industry and in refining methods for the scientific evaluation of equivalence for generic drug products.” In FY 2019, the report says, FDA awarded 14 new
Drugs
Boehringer Ingelheim says the three case study examples in an FDA draft guidance on bridging for drug-device and biologic-device combination products are helpful in illustrating the stepwise approach described in the guidance. However, the company comment says that with the understanding that the three cases describe different scenarios,
Drugs
Manatt Health senior advisor Ian Spatz says the FDA proposal to create a process for agency approval of state-sponsored drug importation plans is not likely to generate significant savings for states or even enough to justify the cost of establishing such a program. Writing online in Stat, Spatz says
FDA Policy/General
Comments Extended on Combo Product Bridging Guide Federal Register notice: FDA extends until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Biologic-Device Combination Products. 02/14/2020 28 ‘No Longer Marketed’ ANDAs Withdrawn Federal Register notice: FDA withdraws approval of