FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dongying Tiandong Pharmaceutical Co. Dongying, Shandong China (11/10): FDA inspected the firm 10/2015 and documented significant deviations from GMPs for active pharmaceutical ingredients. For example, the firm
Drugs
FDA has approved a Lupin Ltd. ANDA for armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg — generic versions of Cephalon’s Nuvigil, indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift work disorder. Brand sales are over $500
Drugs
FDA has accepted for priority review an EMD Serono BLA for avelumab and its use in patients with metastatic Merkel cell carcinoma (MCC). The submission is based on tumor response results from the JAVELIN Merkel 200 trial. Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody and
FDA Policy/General
President-elect Donald Trump has selected House Budget Committee chair Tom Price (R-GA) to serve as HHS secretary in the next administration. Price, who also serves on the House Ways and Means Committee, is known as a fierce critic of Obamacare. By training, he is an orthopedic surgeon who
Devices
FDA e-mails obtained by MobiHealthNews through a Freedom of Information Act request show that FDA and Apple officials have met many times in the last three years, often with the meetings not shown on agency attendees’ calendars. The MobiHealthNews online report details information in e-mails starting in 12/
Drugs
A 10/12-16/15 FDA inspection at Dongying Tiandong Pharmaceutical Co., Shandong, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/10 Warning Letter. Specific deviations included: * failing to adequately investigate and document out-of-specification results according to a
Drugs
A 7/11-7/21 FDA inspection at STI Pharma, Langhorne, PA, found serious violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements, according to an 11/21 Warning Letter from the agency’s Philadelphia District Office. Specific violations included failing to develop adequate written procedures for the surveillance, receipt,
Drugs
The latest FDA report on the status of drug postmarketing requirements and commitments shows that industry has improved its (on-time) submission of annual status reports. Status reports must be submitted within 60 days of the anniversary date of U.S. approval of the original application or an alternate reporting
Biologics
CBER has sent San Diego-based Dr. PRP America an untitled letter over the unapproved marketing of its medical device Dr. PRP Kit for Platelet Rich Plasma (PRP) separation. The letter comes after the Center reviewed the company’s Web site www.drprpamerica.com on 11/2 and found violative
Drugs
CDER has issued a Manual of Policies and Procedures describing the organization, membership, responsibilities, and procedures of the Safety Outcomes Trials (SOT) Subcommittee of the Medical Policy Council. The document says that SOTs are typically large trials designed to assess whether a treatment increases the rate of certain clinical adverse
Drugs
Attorneys Gail Javitt and Jae Kim (DLA Piper) say the HHS final rule on expansion of the national clinical trials database (ClinicalTrials.gov) runs 177 pages and aims to improve public access to information about specified clinical trials involving FDA-regulated products. “The final rule both implements and elaborates on
Devices
Leadership of the American Optometric Association (AOA) met with FDA 11/4 to discuss the group’s concerns with online vision “exams” such as Opternative. “FDA is taking our concerns seriously and is investigating Opternative based on the expansive and detailed complaint AOA filed,” the group says in an online
Devices
Four healthcare organizations are voicing their support for provisions of the MDUFA 4 reauthorization for 2018-2022. The American College of Cardiology says it was interested in three goals in the MDUFA 4 negotiations — a stable, predictable approval pathway; utilization of stakeholder experience; and development of a medical device evaluation
FDA Policy/General
Federal Register Notice: FDA has released an annual report on the status of postmarketing requirements and postmarketing commitments required of, or agreed upon by, holders of approved drug and biological products. To view the report, click here. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA has announced the names of the members who will serve on its Performance Review Board. The board’s purpose is to provide fair and impartial review of senior executive service (SES), senior professional and Title 42 SES Equivalents performance appraisals, bonus recommendations, and pay adjustments. To
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension submitted to OMB related to Applications for Participation in the Medical Device Fellowship Program. To view the notice, click here.
Devices
FDA has posted a guidance on “Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.” The document is intended to highlight the cross-contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes. It also
FDA Policy/General
Federal Register Final Rule: FDA has issued a final rule to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange system authorized by the U.S. Customs and Border Protection Agency, in order for the
Drugs
FDA has released a guidance on “Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)” that describes the conditions under which applicants can use an alternative reporting format, the International Council for Harmonization (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in
Drugs
The U.S. House of Representatives has scheduled an 11/30 floor vote on a revised 21st Century Cures bill that includes $6.3 billion in additional funding to accelerate discovery, development, and delivery of new cures and treatments. The measure would provide $4.8 billion to the National Institutes
Drugs
FDA has partially approved a Teva petition that sought tighter bioequivalence on generic copies of its skeletal muscle relaxant Amrix (cyclobenzaprine hydrochloride), 15 mg and 30 mg extended-release capsules. The agency agreed with Teva’s contentions that generic applicants must demonstrate that their proposed ANDA product is bioequivalent to
FDA Policy/General
FDA has made available a revised draft guidance for industry entitled “Submission of Quality Metrics Data.” The document is part of the agency’s quality metrics reporting program. It describes FDA’s plans for an initial, voluntary phase of this program that will allow the agency to learn more about