Drugs
FDA has released the FDA-483 issued following a 9/11-9/15 inspection at the Dr. Reddy’s drug manufacturing facility in Mirfield, West Yorkshire, UK. The specific observations cited were: * procedures are not established or followed; * cleaning procedures or clean status is not established; and * manually managed materials
Drugs
CDER has issued a Manual of Policies and Procedures, Procedures for Completing and Processing the Form “Annual Status Report Review Form: PMR and PMC Summary,” describing procedures used by Office of New Drugs (OND) staff to (1) verify an applicant’s reported status and explanation of status for postmarketing requirements
Drugs
A 5/8-5/10 FDA inspection at Shandong Vianor Biotech, Shandong, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 9/12 Warning Letter. Specific violations cited were: * failing to ensure that laboratory records included complete data derived from all tests
Drugs
FDA medical reviewers say that the studies submitted by PTC Therapeutics supporting its NDA for Translarna (ataluren) to treat dystrophinopathies [most notably Duchenne muscular dystrophy (DMD)] resulting from nonsense mutations in the dystrophin gene (nmDMD) do not persuasively demonstrate the drug’s effectiveness. The agency’s Peripheral and Central Nervous
Drugs
FDA believes the hurricane destruction to Puerto Rico and medical product makers could be worse than first predicted. In an 9/25 update, FDA commissioner Scott Gottlieb says the agency is “very concerned” about the potential for drug shortages on and off the island. “During and following the storm, we
Devices
CDRH director Jeffrey Shuren and two other Center executives say they have seen increasing evidence of the benefits of soliciting patient feedback through the Patient Preference Initiatives that was launched in 2015. Writing in an FDA Voice article, Shuren and his colleagues say that in August the Center cleared an
Drugs
Public Citizen says there is no justification for FDA not seeking public input before issuing a final guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” In its comments, the advocacy group says FDA reported it had determined
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are labeled for a new use with an approved, marketed drug when the drug sponsor does not wish to collaborate on the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Classification of Products as Drugs and Devices & Additional Product Classification Issues.” The document finalizes two related draft guidance documents issued in 2011. It provides the agency’s current thinking on approaches for classifying products as drugs and devices,
Devices
In its Pulse of the Industry 2017, the EY medtech consulting firm says it’s only a matter of time until FDA enforces stringent regulations for the security of medical devices. The report notes that in 8/2017, the agency demonstrated how closely it continues to monitor potential cyber vulnerabilities,
Drugs
FDA has denied a US WorldMeds 7/21/15 petition asking that the agency require specific conditions for any application for a drug-device combination product containing apomorphine, intended for use in the advanced Parkinson’s disease population. Specifically, the petition asked that FDA: * require applicants to demonstrate that their
Devices
The Justice Department has told the 3rd Circuit Court of Appeals that a federal district court decision in a case involving Smith & Nephew hip replacement and resurfacing procedure medical devices held that some tort claims are expressly preempted, when they are not. “To the extent these claims are not
Devices
FDA commissioner Scott Gottlieb says the agency’s new “Pre-Cert for Software” pilot program is moving forward with the selection of nine company participants in the program — Apple, Fitbit, Google, Johnson & Johnson, Phosphorus, Roche, Samsung, Tidepool, and Verily. Under the program, CDRH will become a “certifier of firms
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Shandong Vianor Biotech Co. Linyi Shandong, China (9/12): FDA inspected the firm in May and cited significant GMP violations with finished pharmaceuticals. For example, the firm failed to
Devices
FDA has accepted for review a TherOx Inc. PMA for its Supersaturated Oxygen (SSO2) Therapy system, intended for use in reducing infarct size and improving outcomes in anterior acute myocardial infarction (AMI) patients treated within six hours of symptom onset. While percutaneous coronary intervention is the standard of care in
Drugs
FDA has accepted for review an Eisai supplemental NDA for Lenvima (lenvatinib) for use in first-line treatment of patients with hepatocellular carcinoma (liver cancer). The submission is based on data from the pivotal Phase 3 REFLECT trial. In the study, lenvatinib reportedly demonstrated a treatment effect on overall survival
Drugs
FDA and the HHS Office for Human Research Protections have issued a guidance on “Minutes of Institutional Review Board (IRB) Meetings.” The document is intended to harmonize the agencies’ regulatory requirements and guidance for human subject research. It outlines how to prepare and maintain minutes of IRB meetings that meet
FDA Policy/General
Federal Register notice: FDA has published a list of premarket approval applications that have been approved from 7/1/2016 through 6/30/2017. There were no denial actions during this period. The list provides the manufacturer’s name, the product’s generic name or the trade name, and the
Devices
FDA has updated a 2016 safety alert to transplant surgeons and cardiologists about additional data that 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
Devices
FDA and several ophthalmic-related medical associations are holding a 10/23 workshop entitled “Ophthalmic Digital Health” to discuss factors to consider when evaluating safety and effectiveness of ophthalmic digital health devices as well as ways to improve device safety and effectiveness. Agency officials will outline perspectives on ophthalmic mobile
Drugs
FDA has made available a guidance on “Expedited Programs for Serious Conditions — Drugs and Biologics.” The document outlines the four FDA programs — fast track designation, breakthrough therapy designation, accelerated approval and priority review designation — intended to facilitate and expedite development and review of new drugs to address unmet medical needs.
Drugs
FDA is deploying additional staff to Puerto Rico to work with pharmaceutical and device companies to prevent shortages of medically necessary drugs and devices, as well as assist with public health needs after Hurricane Maria decimated the island. “There are many challenges ahead, but much of the hurricane response over