Drugs
FDA has published a draft guidance, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment, with recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome. The document incorporates recommendations the agency received at a 12/2017 advisory committee meeting
FDA Policy/General
Federal Register notice: FDA has established a docket to obtain information and comments that will assist it in determining whether to establish a pilot program for the toxicological and quality evaluation of novel excipients intended for use in human drugs. Historically, FDA has not reviewed the safety of novel excipients
Devices
A recent CDRH Industry Basics Webcast covered Webpage and multimedia resources available for industry on a variety of CDRH topics and then gave basic information on the 513(g) request for information process and the custom device exemption process. In the show’s first hour, CDRHer Ifearyi Uwemedimo discussed how
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Spark Therapeutics Luxturna (voretigene neparvovec-rzyl), indicated for treating patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. The review period is 3,809 days, which includes 3,591 days that occurred during the testing
Devices
A nonpartisan Tax Foundation report issued by AdvaMed says that if the medical device tax continues due to congressional inaction, there will be a loss of 21,390 U.S. medical technology jobs in the next two years and a $1.74 billion decline in the nation’s gross national
FDA Policy/General
The Medical Information Working Group (MIWG) says FDA should include recent Supreme Court First Amendment free speech decisions in its ongoing analysis of manufacturer communications regarding unapproved uses of approved or cleared medical products. In a comment to the agency docket on the subject, MIWG says FDA should ensure that
FDA Policy/General
Federal Register notice: FDA has announced a 12/17 Oncologic Drugs Advisory Committee meeting. During the morning session, the committee will discuss an AstraZeneca supplemental NDA for Lynparza (olaparib) tablets, indicated for maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease
Drugs
The Justice Department says a deferred prosecution agreement reached with Rising Pharmaceuticals, a New Jersey generic drug company, will resolve charges through the company’s admission that it conspired with a competing generic drug company to fix prices and allocate customers for benazepril HCTZ. A one-count felony charge filed
Drugs
FDA has approved a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Approval is based
Drugs
The White House Council of Economic Advisors (CEA) says that H.R. 3, the Lower Drug Costs Now Act of 2019, could keep as many as 100 new lifesaving drugs off the market. The CEA also estimates that by limiting access to lifesaving drugs, the bill would reduce Americans’ average
Devices
FDA has granted RightEye a breakthrough device designation for the RightEye Vision System and its use in diagnosing Parkinson’s Disease. Currently, no single test is capable of definitively diagnosing Parkinson’s disease and physicians instead rely on a variety of neurological examinations designed to confirm the clinical diagnosis, and
Drugs
Aquestive Therapeutics has completed a rolling NDA submission for Libervant (diazepam) Buccal Film for managing seizure clusters. Libervant is administered from inside the cheek in selected, refractory patients with epilepsy on stable regimens who require intermittent use of diazepam to control bouts of increased seizure activity. Aquestive says it is
Devices
AdvaMed says FDA should “adopt a practice of full transparency regarding its plans for submissions by electronic format.” In comments to an agency draft guidance on providing regulatory submissions for medical devices in electronic format, the association says that information technology systems are complex and costly, and new systems require
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: American Contract Systems, Houston, TX (11/9): FDA inspected the firm in September and found Quality System Regulation violations with various surgical
Drugs
The House Energy and Commerce Oversight and Investigations Subcommittee has planned a 12/10 hearing entitled “Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program.” It will be held at 10 am in the John D. Dingell Hearing Room, 2123 Rayburn House Office Building. “Over
Drugs
FDA has released the FDA-483 issued following a 9/9-9/19 inspection at AnazaoHealth, a Las Vegas, NV, outsourcing facility. The three inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions; * the flow of
Drugs
At the 11/16-11/10 International Council on Harmonization (ICH) meeting in Singapore, the ICH management committee reelected CDER associate director for strategic initiatives Theresa Mullin to a one-year term as the committee chair. A meeting report also indicates that the assembly regulatory members adopted the new ICH
Devices
A 9/9-10/4 FDA inspection at the American Contract Systems medical device operations in Houston, TX, found Quality System Regulation violations in the firm’s work as a medical device manufacturer and contract sterilizer of various surgical trays/kits for hospital use. A just-released 11/9 Warning
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Amgen’s Aimovig (erenumab-aooe), indicated for preventing migraines in adults. The regulatory review period is 2,042 days, which includes 1,675 days that occurred during the testing phase and 367 days during the
FDA Policy/General
Two weeks after sailing though his confirmation hearing (see earlier story), the Senate Health, Education, Labor & Pensions Committee 12/3 voted 18 to 5 to advance Stephen Hahn’s nomination to serve as FDA commissioner to the full Senate for consideration. “Dr. Hahn has extensive medical and research experience
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Adaptive Designs for Clinical Trials of Drugs and Biologics.” The document provides recommendations on the appropriate use of adaptive designs for drug clinical trials. It describes important principles for designing, conducting, and reporting the results from an adaptive clinical
Devices
A bipartisan congressional group has written to HHS and its Centers for Medicare and Medicaid Services supporting a recommendation that the device identifier portion of unique device identifiers (UDIs) be added to the standard information on electronic health insurance claims forms. Signing the letters were Sens. Chuck Grassley (R-IA)