FDA Policy/General
FDA has approved Bausch + Lomb’s Ultra contact lenses for extended wear for up to six nights and seven days of continuous wear. The contact lenses include the company’s MoistureSeal technology, a patented combination of material and manufacturing process that helps to maintain 95% of lens moisture for 16
Drugs
FDA has completed a pre-approval inspection of the Biocon sterile drug manufacturing facility in Bangalore, India, and issued an FDA-483 with seven inspection observations. In a filing with the National Stock Exchange of India, Biocon says the inspection observations “are largely procedural and aimed at continuous improvement.” It
Drugs
A Fresenius decision last month to terminate the company’s $4.7 billion merger agreement with generic drug company Akorn was based on alleged “blatant fraud at the very top level” at Akorn, Fresenius said in a recent court filing. Last month, Fresenius said its decision was based on, among
Devices
FDA has approved a Medtronic PMA for its Deep Brain Stimulation (DBS) therapy as adjunctive treatment for reducing the frequency of partial-onset seizures, in individuals 18 years of age or older who are refractory to three or more antiepileptic medications. “DBS therapy for epilepsy delivers controlled electrical pulses to
Drugs
The 7th Circuit Court of Appeals issued in March a powerful endorsement of the learned intermediary doctrine in multi-district litigation involving a Zimmer knee implant. Attorney Jonah Knobler (Patterson Belknap) writes in a Washington Legal Foundation Legal Opinion Letter that the court rejected arguments saying that the learned intermediary
Drugs
Karyopharm Therapeutics says it will submit an NDA in the second half of this year for selinexor for multiple myeloma after reporting positive top-line results from the Phase 2b STORM study. Data from the study showed that selinexor achieved a 25.4% overall response rate (ORR), which included two
Devices
FDA has cleared a Conavi Medical 510(k) for its Novasight Hybrid System, which allows simultaneous imaging of coronary arteries with both intravascular ultrasound and optical coherence tomography. Such imaging is typically used by interventional cardiologists to image coronary anatomy during angioplasty and stenting procedures, the company says. The device
Drugs
FDA has approved a Novartis NDA for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, and involvement of lymph nodes, following complete resection. Approval was based on data from COMBI-AD, a Phase 3 study of 870
Drugs
A 3/13-3/23/17 FDA inspection at Fusion IV Pharmaceuticals, a Los Angeles, CA, 503B outsourcing facility doing business as Axia Pharmaceuticals, found multiple violations, including that drug products produced by the firm failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic
Drugs
In a Washington Legal Foundation webinar, attorneys John Boese and Douglas Baruch (Fried Frank) outlined the contents of two Justice Department internal memos dealing with False Claims Act cases and their impact on whistleblowers and federal prosecutors. Boese said that a 1/10 memo by Michael Granston states the department’
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product maker. It can be accessed by clicking on the link following the letter. Fusion IV Pharmaceuticals (dba Axia Pharmaceutical) Los Angeles, CA (2/21): FDA inspected the drug outsourcing facility 3/2017 and it noted that
Devices
FDA has cleared a Med-El USA 510(k) for its next generation non-surgical bone conduction hearing technology called AdHear. The adhesive adapter is placed onto the skin behind the ear and is worn for three to seven days at a time. A lightweight audio processor is clicked on
Drugs
Commenting on an International Council on Harmonization draft guidance on statistical principles for clinical trials addendum on estimands and statistical analysis in clinical trials, Pharmaceutical Research and Manufacturers of America (PhRMA) says that additional clarity is needed in several areas to help reduce clinical trial complexity and increase clarity in
Drugs
Actelion Pharmaceuticals has filed a supplemental NDA to expand the indication for Opsumit (macitentan) to include treating adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) to improve exercise capacity and pulmonary vascular resistance (PVR). The submission is based on data from the MERIT-1 trial, which showed significant improvements in
Devices
FDA has approved Medtronic’s Infuse Bone Graft in new spine surgery indications. The device is now approved for use with additional spine implants made of polyetheretherketone in oblique lateral interbody fusion and anterior lumbar interbody fusion procedures. Infuse is intended to be used with certain Medtronic interbody fusion devices
Devices
Attorney Allyson Mullen (Hyman, Phelps & McNamara) says FDA made significant changes in the finalized 4/13 next generation sequencing guidance (NGS) without any explanation for why its thinking on the subject has changed. Writing in her firm’s FDA Law Blog, Mullen says the substantive changes in the guidance
Drugs
FDA is reminding drug sponsors that although the compliance date for submitting Type 3 master drug files in electronic common technical document (eTCD) format has been extended one year to 5/5/19, other eCTD deadlines remain unchanged and drug master files other than Type 3 and commercial INDs are
Drugs
The CDER Ombudsman 2017 annual report shows a 28% decrease in the number of stakeholder contacts from 289 in 2016 to 207 in 2017. “Based upon percentage decreases from 2016 to 2017,” the report says, “the two demographic categories with the most significant drops were the number of whistleblowers, which
Drugs
The American Association for Cancer Research says it has four recommendations in response to the FDA 3/15 public meeting on the structure and function of the Oncology Center of Excellence (OCE). The comment letter says (1) OCE should have clear, final signoff authority for all product reviews associated with
Drugs
UCB BioPharma says it appears that an International Conference for Harmonization draft guidance on statistical principles for clinical trials addendum on estimands and sensitivity analysis in clinical trials “still does not give real guidance on which estimands (specifically, handling strategies for intercurrent events) are to be used. The company’s
Devices
Cooper Union adjunct professor of biomedical engineering William Hyman says his experiment seeking information on a cardiac ablation catheter based on its unique device identifier (UDI) found that there can be too little information available. Writing in an AAMIBlog post, Hyman says FDA has said a benefit of using UDIs
Drugs
CDER deputy director for regulatory programs Douglas Throckmorton says that Controlled Substances Staff (CSS) acting director Dominc Chiapperino has been promoted to be the director. In a note to staff, Throckmorton says CSS oversees and provides consultation throughout FDA regarding drugs of abuse, which includes assessing drugs for abuse potential