Drugs
Adamas Pharmaceuticals has submitted an NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules, indicated for treating levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. The submission is supported by efficacy and safety data from three placebo-controlled trials: EASED, EASE LID and EASE LID 3. The trials
Devices
FDA has cleared a SeaSpine Holdings 510(k) for its Shoreline ACS Anterior Cervical Standalone System, which features TruProfile technology. The device offers a low profile plate that is designed to minimize cephalad-caudal encroachment onto the vertebral bodies and maximize the distance from adjacent disc spaces, according to the
Drugs
Salix Pharmaceuticals is petitioning FDA not to approve an ANDA citing any strength of its Xifaxan (rifaximin) as the reference-listed drug unless it conforms with an extensive series of conditions submitted by Salix. The company says that any ANDA that references either strength or any indication of Xifaxan as
Drugs
Under terms of the Generic Drug User Fee Amendments of 2012, FDA is to prepare a yearly list of regulatory science priorities for generic drugs based on input from industry and other stakeholders. The agency has released this list of priorities for FY 2017: * post-market evaluation of generic drugs,
Drugs
FDA has awarded Engility Holdings a $112 million five-year contract for computational science and bioinformatics services. As part of the contract, the company will provide security, operations and maintenance, and technical support for scientific computing environments and systems. “Engility will help the FDA build fast, reliable and adaptable high
Devices
New funding to be phased in over the course of MDUFA 4 will be used to implement proposed MDUFA 4 enhancements. A summary of draft recommended legislative changes dated 10/25 shows new funding of $47,419,400 in FY 2018, $54,849,400 in FY 2019, $64,339,400
Devices
The Small Biotechnology Business Coalition commends FDA for its 7/27 draft guidance on using data and evidence collected outside of the traditional clinical trial context to support medical device regulatory decisions. The group suggests these additions to improve the impact and clarity of the draft: * stipulating that economic cost-
Devices
An FDA update to transplant surgeons and cardiologists says that additional data continue to indicate that there is a higher mortality rate for a subgroup of patients requiring pre-implant circulatory rescue interventions when using SynCardia’s Temporary Total Artificial Heart Companion 2 Driver System, as compared to the previous
Drugs
The CDER Office of Generic Drugs has issued a Manual of Policies and Procedures (MAPP) for review of investigational NDAs submitted for bioavailability or bioequivalence studies, known as Bio-INDs. The MAPP says the term Bio-IND distinguishes such studies from INDs for investigational new drug products submitted to the
Drugs
Public Responsibility in Medicine and Research (PRIM&R) says it agrees with the need for additional guidance on institutional review boards (IRBs), but has concerns about a guidance with an IRB written procedures checklist issued by FDA and the HHS Office for Human Research Protections. The group cautions that
Drugs
The Biotechnology Innovation Organization (BIO) says in comments on two draft FDA guidances on compounded drug products that it has long supported a prohibition on compounding of commercially available FDA-approved products unless the drugs are medically necessary to address a unique individual patient need not met by the approved
Drugs
The International Society for Pharmaceutical Engineering says a draft FDA guidance on data integrity and compliance with current good manufacturing practice provides greater clarity on many issues surrounding data integrity, but further clarifications are needed. The group says the guidance needs to capture important risk-based principles and should clarify
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection related to “Format and Content Requirements for OTC Drug Product Labeling — 21 CFR Part 201.” The regulations in Part 201 require OTC drug product labeling to include uniform headings and subheadings,
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.” The document is intended to assist sponsors in developing drugs for such conditions. It addresses FDA’s current thinking on the overall clinical development program, with
Drugs
The 7th Circuit Court of Appeals has rejected a plaintiff’s argument that the FDA Amendments Act of 2007 (FDAAA) changed generic drug labeling requirements such that failure-to-warn claims are no longer preempted. Attorney Stephen McConnell (Reed Smith) writes online in the Drug and Device Law blog that
Drugs
FDA and the European Union are moving forward with a GMP inspection mutual agreement to recognize each other’s inspectional activities, with such an agreement being finalized in January. The agreement is part of the negotiations under the Transatlantic Trade and Investment Partnership (TTIP). There are still a number of
Devices
FDA has approved Medtronic’s CoreValve Evolut R 34 mm valve, said to be the largest sized transcatheter aortic valve replacement (TAVR) system available in the U.S. The device is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size
FDA Policy/General
Federal Register Proposed Rule: An FDA proposed rule seeks to remove an “essential uses” designation for certain ozone-depleting substances (ODSs) under the Clean Air Act. The action, if finalized, will remove the essential-use exemption for anesthetic drugs for topical use on accessible mucous membranes of humans where a
FDA Policy/General
Federal Register Proposed Rule: An FDA proposed rule seeks to remove an “essential uses” designation for certain ozone-depleting substances (ODSs) under the Clean Air Act. The action, if finalized, will remove the essential-use exemption for sterile aerosol talc administered intrapleurally by thoracoscopy for human use and for metered-
Devices
FDA has approved an Ethicon BLA supplement for an expanded indication for Evarrest Fibrin Sealant Patch, indicated for stopping problematic bleeding during surgery. It now supports the product’s use as an adjunctive hemostat across a broad range of challenging patient types and surgical situations. Approval is based on data
Devices
FDA has cleared a Spineology 510(k) for the Rampart Duo Interbody Fusion System, which the company describes as the first device of its kind to combine PEEK (polyether ether ketone), titanium, and graft containment mesh elements. The device is designed to allow for “decreased retraction requirements when compared to
Drugs
Harvard Medical School professors Aaron Kesselheim and Jerry Avorn say that FDA’s recent approval of eteplirsen (Exondys 51) as a treatment for Duchenne muscular dystrophy provides “a worrisome model for the next generation of molecularly targeted therapies: demonstrate a slight difference in a laboratory test, activate the patient community,