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Commenting on an International Council on Harmonization draft guidance on statistical principles for clinical trials addendum on estimands and statistical analysis in clinical trials, Pharmaceutical Research and Manufacturers of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
FDA Policy/General
Guide on Unapproved New Animal Drug Index Federal Register notice: FDA has made available a guidance entitled ‘‘The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.’’ The document describes the process for adding a new animal drug to the index. To view the notice, click here. 4/
Biologics
FDA has released two charts showing the number of HCT/P (human cells, tissues, and cellular and tissue-based products) inspections performed in fiscal years 2013-2017. They ranged from 598 in FY 2015 to 671 in FY 2013. There were 621 inspections in FY 2017. The number of inspections
Drugs
FDA has issued a list of Medication Guides, showing six that are new and 30 that have been updated since 3/2017. New guides were issued for Kempharm’s Apadaz, Merck’s Ilumya, Bracco Diagnostics’ Multihance, Intercept Pharmaceuticals’ Ocaliva, Synergy Pharmaceuticals’ Trulance, and rtis’ Zortress. Guides were updated for AstraZeneca’
Drugs
CDER has issued a Manual of Policies and Procedures outlining the policies of the Office of Pharmaceutical Quality (OPQ) for granting or denying a request for an expedited review for NDA and BLA prior approval supplements that (1) involve chemistry, manufacturing, and controls changes and (2) are managed by OPQ.
Drugs
Members of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Committee voted 15-5-1 that the post-marketing PRECISION study demonstrates that Pfizer’s Celebrex (celecoxib) has comparable cardiovascular safety with naproxen (Aleve) and ibuprofen (Motrin). If FDA accepts the recommendation, the study results will be
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled ‘‘The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.’’ The document describes the process for adding a new animal drug to the index. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled ‘‘Multiple Function Device Products: Policy and Considerations.’’ This draft guidance provides the agency’s regulatory approach for products with multiple functions, including at least one device function, in accordance with the 21st Century Cures Act. To view the notice,
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled ‘‘Clinical Trial Imaging Endpoint Process Standards.’’ The document is intended to assist sponsors in optimizing the quality of imaging data obtained in clinical trials that will support product approvals. It focuses on imaging acquisition, display, archiving, and interpretation process standards