FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids.” The document discusses the agency’s intention not to enforce certain conditions for sale for hearing aid devices. Specifically, it does not intend to enforce the medical
Devices
Washington Legal Foundation (WLF) says there is “much to commend” in an FDA draft guidance on when to submit a 510(k) for a change to an existing device. It also offers several suggested changes. “While the current guidance document (issued in 1997) has served manufacturers well for many years,
Drugs
Ophthotech says two Phase 3 studies evaluating its wet age-related macular degeneration (AMD) drug Fovista (pegpleranib) failed to meet the pre-specified primary endpoint of mean change in visual acuity at 12 months. The studies are evaluating Fovista in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy. The two
Devices
The Medical Device Manufacturers Association (MDMA) says it is concerned about an FDA estimate that there are no capital costs or operating and maintenance costs associated with the agency’s proposed collection of information on the unique device identification system. “This is concerning as this assumption suggests that medical device
Drugs
FDA has issued Alkem Laboratories a three-item Form-483 after an inspection (12/5-9) recently concluded at the firm’s Ankleshwar, India active pharmaceutical ingredient manufacturing plant. The company said in a financial release that it is preparing a detailed response with “adequate corrective and preventive measures” to
Devices
Centurion has begun a Class 1 recall of its Multi-Med Single Lumen Catheters due to excess material at the tip that may split or separate. If this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. “This can result in
FDA Policy/General
DEVICES Class 2 for Computerized Concussion Assessment Aids Federal Register Final Order: FDA has classified Computerized Cognitive Assessment Aids for Concussion into Class II (special controls). The special controls that will apply to the device are identified in the order and will be part of the codified language for the
Drugs
FDA officials writing in the 12/8 New England Journal of Medicine express caution about “real world evidence” and its potential to contribute efficiently to current knowledge gained from traditional clinical trials, “whose well-known limitations make it difficult to generalize findings to larger, more inclusive populations of patients, providers,
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The document is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the
Drugs
Several former pharmaceutical executives and managers at Insys Therapeutics were arrested 12/8 on charges that they led a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers. The indictment alleges that former CEO Michael L. Babich, former sales VP Alec
Devices
ProNova Solutions has received FDA 510(k) clearance for its SC360 proton therapy system, a compact 360-degree pencil beam scanning proton therapy system capable of treating patients at all angles without moving the patient. The company says the device features pencil beam scanning and advanced imaging with cone-beam
FDA Policy/General
Federal Register Notice: FDA has established a docket to obtain comments on the final assessment of the “Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs).” Also, a 3/27/2017 public meeting has been annouced where
Drugs
FDA has denied a citizen petition from Adapt, the manufacturer of Narcan (naloxone) Nasal Spray, 4 mg, indicated for treating opioid overdose, asking that it publish a guidance for all naloxone products to identify the “optimal fixed initial dose for each route of administration as well as the required exposure
Drugs
FDA has accepted for priority review an AstraZeneca BLA for durvalumab, a PD-L1 human monoclonal antibody for treating patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after one standard platinum-based regimen. The agency has set a user fee review target for
Devices
FDA has expanded approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions (PCI). In 2016, the agecny approved Impella CP for up to four days of use to treat patients suffering from cardiogenic shock. The expanded approval allows for
Drugs
Gilead Sciences has submitted an NDA for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for treating direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The submission is based on data from two
Devices
Attorneys Jeffrey Shapiro and Jennifer Newberger (Hyman, Phelps & McNamara) say the 21st Century Cures Act, approved by lopsided majorities in the House and Senate and expected to be signed by the president, contains “a host of provisions intended to improve how FDA reviews and approves drugs and medical devices.
FDA Policy/General
Former FDA deputy commissioner Scott Gottlieb, who served under George W. Bush, has reportedly been added to the short list of candidates president-elect Donald Trump is considering for FDA commissioner under his administration. Gottlieb, who is also serving on the Trump transition team, is a resident fellow at the
Drugs
Bristol-Myers Squibb has entered into a settlement agreement with 43 states to resolve allegations the company used false and misleading representations to promote its antipsychotic drug Abilify. Under the agreement, Bristol-Myers Squibb will pay $19.5 million and implement marketing, sales, disclosure and other reforms aimed at avoiding
Drugs
The Health Industry Distributors Association says that a delay in issuing federal licensure regulations for pharmaceutical wholesale distributors has led to state inspectors and state boards developing varying interpretations and requirements, many of which the association says are not only inconsistent with the Drug Supply Chain Security Act but also
Devices
AdvaMed says it supports the principles and concepts in an FDA draft guidance on deciding when to submit a 510(k) for a software change to an existing medical device. The trade association provides recommendations on specific examples in the draft and more detailed comments. “Notwithstanding these comments,” it says,
Drugs
FDA has issued a guidance, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, to aid “trading partners” (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product as defined in the Drug Supply Chain Security Act (DSCSA) and terminating notifications. The document says that as