Devices
Medical Device Pre-Cert FAQs
CDRH has released frequently asked questions (FAQs) about the new medical device pre-certification pilot program. The document covers 13 questions about eligibility for the program and how it will operate.
David McFarland
Drugs
FDA Sued Over Orenitram Orphan Drug Denial
United Therapeutics is suing FDA in DC federal court over the agency’s denial of orphan drug exclusivity for the company’s Orenitram (treprostinil) extended-release tablets to treat pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity. Attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’
Devices
FDA Alert on Obesity Balloon Devices After 5 Deaths
FDA has issued a safety alert update based on receiving five reports of unanticipated deaths since 2016 in patients with liquid-filled intragastric balloon systems used to treat obesity. “Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual
Drugs
FDA Raises Concerns with Vital Rx Sterile Drugs
FDA has issued a safety alert on sterile drug products that are produced and distributed nationwide by Vital Rx Inc. (dba Atlantic Pharmacy and Compounding, Pompano Beach, FL) due to lack of sterility assurance. During a recent inspection of Atlantic Pharmacy, agency investigators observed insanitary conditions, including poor sterile production
Drugs
Panel to Review Gadolinium Retention in Contrast Agents
Federal Register notice: FDA has announced a 9/8 Medical Imaging Drugs Advisory Committee meeting. Panel members will discuss the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents for magnetic resonance clinical imaging procedures. To view the notice, click
Drugs
FDA Sued Over Absent Petition Response
Pharmaceutical Manufacturing Research Services (PMRS), a contract drug manufacturer, is suing FDA in Pennsylvania federal court seeking an order requiring the agency to respond “promptly” to the company’s petition asking FDA not to approve Inspiron Delivery Services’ Roxybond (oxycodone hydrochloride) tablets, pending the agency’s substantive responses to two
FDA Policy/General
FDA HQ Environmental Impact Statement
The General Services Administration (GSA) says it will prepare an environmental impact statement (EIS) for a proposed master plan to support a significant staff increase at FDA’s White Oak headquarters. An 8/11 Federal Register notice says that a 1997 EIS analyzed the impacts from consolidation of 5,975
Drugs
Sunshine Needed on Doc Drug Company Payments: Grassley
Sen. Charles Grassley (R-IA) says that a recent study published in the American Journal of Public Health that found that between 2013 and 2015, 68,177 doctors received more than $46 million in payments from drug companies promoting opioids “is exactly the kind of research the sunshine disclosures should
Devices
PreCert Webinar Materials Available
CDRH has released materials from its 8/1 webinar on the digital health precertification pilot program. There is an audio file of the presentation, a transcript of the presentation, and the slides used during the program. The software precertification pilot program is described as a voluntary pilot program that will
Drugs
Court Denies Amgen Epogen Biosimilar Patent Appeal
The Court of Appeals for the Federal Circuit has denied an Amgen appeal of a lower court decision that rejected the company’s attempt to compel discovery from Hospira in a patent dispute over a biosimilar version of Amgen’s Epogen. Amgen claimed that Hospira did not live up to
Drugs
FDA Clears Optovue Epithelial Mapping Software
FDA has cleared an Optovue 510(k) for its epithelial thickness mapping software for quantitative measurements of the epithelial and stromal layers of the cornea. Epi-mapping is intended to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population, according to the company.
Drugs
International Labs Recalls Mislabeled Pravastatin
International Laboratories has recalled one lot of pravastatin sodium tablets USP 40 mg packaged in bottles of 30 tablets due to mislabeling. The product is labeled as pravastatin sodium but the lot contained bupropion hydrochloride 300 mg tablets. “If a subject mistakenly takes bupropion, common side effects include: nausea, vomiting,
FDA Policy/General
Guide on Expiry Dating for Unit Dose Repackaging
Federal Register notice: FDA has announced the availability of a revised draft guidance on “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.” The document describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and instructs
Devices
FDA Issues Medical Device Development Tool Guidance
FDA has released a final guidance, Qualification of Medical Device Development Tools, formalizing the medical device development tools (MDDT) program that started with a 2013 pilot. CDRH says it believes the policy will facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means
Drugs
FDA Grants, Denies Prandin/Plavix Petition
FDA has granted in part and denied in part a 12/28/16 Public Citizen petition seeking label changes for medications containing repaglinide (Prandin, PrandimMet) and clopidogrel (Plavix). The petition specifically asked the agency to require that: * the label of repaglinide-containing medications include information on a serious drug-drug
Drugs
ADA Wants OTC Oral Health Monograph Review
The American Dental Association is asking FDA to open a public rulemaking process to review and update several over-the-counter drug monographs for oral health drug products. The petition asks for a review and update of the monographs on OTC Anticaries Drug Products, OTC Oral Healthcare Drug Products, OTC
Drugs
China Joins ICH Drug Harmonization
CDER Office of Strategic Programs director Theresa Mullin says she was in China recently when that country’s Food and Drug Administration submitted its membership application to the International Council for Harmonization (ICH). That action is important, she writes in an FDA Voice blog post, because drug development is increasingly
Drugs
Allergan Asks for Restasis ANDA Restrictions
Allergan is petitioning FDA to refuse to approve any pending ANDA for cyclosporine ophthalmic emulsion for which its Restasis is the reference-listed drug that relies on in vitro or other non-clinical analyses, and does not rely on one or more appropriately designed clinical endpoint bioequivalence studies, as previously
Drugs
OGD Seeing Record Year with ANDA Approvals
With two months to go this fiscal year, CDER’s Office of Generic Drugs (OGD) is on track to eclipse last year’s record approval (651 ANDAs) for generic drugs. Already through July, OGD has approved 633 ANDAs, according to an agency tally. OGD refuse-to-receive actions have been
Devices
Stimwave StimQ Nerve Stimulator Cleared by FDA
FDA has cleared a Stimwave 510(k) for the StimQ Peripheral Nerve Stimulator (PNS) System, a wireless, micro-technology neuromodulation device for treating chronic peripheral nerve pain. The clearance enables the pain sufferer to have frequent and necessary MRI scans of any part of their body without removing the implant,
Drugs
Mylan Blames FDA for Generic Drug Approval Delays
Mylan CEO Heather Bresch told an 8/9 financial outlook conference call that regulatory delays slowing its generic forms of the asthma drug Advair and multiple sclerosis treatment Copaxone are tied to reorganization and new priorities at FDA. “We honestly see the administration as the barrier, and not the science,
Drugs
Priority Review for Genentech sNDA for Zelboraf
FDA has accepted for priority review a Genentech supplemental NDA for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare, serious blood disease characterized by the abnormal multiplication of certain white blood cells called histiocytes. The therapy was also granted breakthrough therapy designation for