Drugs
Lachman Consultants says that three issues that drive drug companies crazy currently are (1) getting resolution of compliance status after inspection or re-inspection; (2) getting a straight answer from FDA; and (3) what to do about maximum daily exposure issues relative to the inactive ingredient database. “Most of the
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection related to CDRH’s Pre-Submission Program for Medical Devices. Under the program, FDA provides recommendations on the information that should be submitted in a Pre-Submission package and procedures that
Devices
FDA has cleared an Avinger 510(k) for the Pantheris Lumivascular atherectomy system for use in Peripheral Artery Disease (PAD) patients for therapeutic and diagnostic purposes. The expanded indication clarifies that, in addition to treatment of PAD, Pantheris may be used by physicians to identify the vessel lumen and wall
Drugs
Former FDA associate commissioner Peter Pitts says that FDA could follow principles to improve drug labeling in a way that would make it easier for doctors to determine if off-label prescribing would be good for their patients. Writing in a Forbes online post, he notes that drug companies continue
Drugs
A just-released FDA-483 details observations from a 6/1-6/10 inspection of Akorn Pharmaceuticals, Decatur, IL. Specific observations included: * failing to record and justify deviations from written production and process control procedures; * failing to fully follow responsibilities and procedures applicable to the quality control unit; * failing to
Drugs
Is something amiss at CDER in the wake of last month’s controversial approval of Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys 51 (eteplirsen)? One may suspect this after CDER Office of New Drugs director John Jenkins took an unprecedented opportunity to criticize (see presentation) the drug’s development and
Drugs
Attorney James Beck (Reed Smith) says the 3rd Circuit Court of Appeals properly rejected the Sheller law firm’s appeal of a lower court decision saying it lacked standing to sue FDA to compel the agency to approve its citizen petition on Risperdal use in children. Writing in a Drug
Devices
The Biotechnology Innovation Organization (BIO) says it welcomes the release of two FDA draft guidances on regulating next generation sequencing (NGS) tests. Commenting specifically on the guidance dealing with use of public human genetic variant databases to support clinical validity for next generation sequencing-based in vitro diagnostics, BIO says
Drugs
A 9th Circuit Court of Appeals three-judge panel has ruled that Physicians for Integrity in Medical Research has no standing to sue FDA over the agency’s decision not to revoke its approval of the chronic obstructive pulmonary disease drug roflumilast (AstraZeneca’s Daliresp). In its 2011 suit, the
FDA Policy/General
Federal Register Notice: FDA is seeking public comments on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-agency activities. “Emerging sciences, such as synthetic biology, are expected to impact FDA regulated products in the relatively near term,” the agency says. In response, the agency
Drugs
FDA has granted accelerated approval to Eli Lilly for its soft tissue sarcoma (STS) drug Lartruvo (olaratumab) and its use with chemotherapy drug doxorubicin in those who cannot be cured with radiation or surgery. Lartruvo is a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody. “When stimulated, PDGF receptors
FDA Policy/General
A Hillary Clinton presidential campaign hacked email released by Wikileaks shows how former president Bill Clinton and other top Democrats lobbied Biogen and FDA to gain a compassionate use exemption for Tysabri (natalizumab) and its use in a dying top donor, Fred Barron. At the time (2008), the drug was
Drugs
FDA has approved Genentech’s Tecentriq (atezolizumab) for treating people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Approval is based
FDA Policy/General
Federal Register Notice: FDA is seeking comments on extending a collection of information on requirements for medical device PMA submissions. The requirements also cover recordkeeping and maintenance of records. For example, records used to trace patients and the organization and indexing of records into identifiable files to ensure the device’
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Amgen’s Repatha (evolocumab) for patent extension purposes. The agency has calculated the regulatory review period as 2,267 days. Of this time, 1,901 days occurred during the testing phase of the regulatory review. To view this notice,
Biologics
CBER says it has undergone an internal restructuring as of 10/16 intended to allow it to more efficiently accomplish its regulatory mission. The new structure includes an Office of Blood Research and Review, an Office of Vaccines Research and Review, and an Office of Tissues and Advanced Therapies (formerly
Drugs
FDA has accepted an AstraZeneca NDA re-submission for sodium zirconium cyclosilicate (ZS-9), indicated for treating hyperkalemia (high potassium level in the blood serum). A complete response letter was sent in May to the company that identified observations cited during a pre-approval manufacturing inspection. The agency did not
Drugs
FDA has placed a clinical hold on a Regeneron Pharmaceuticals and Teva Pharmaceutical Industries Phase 2b clinical trial of fasinumab in patients with chronic low back pain. Fasinumab is an investigational Nerve Growth Factor (NGF) antibody in clinical development for osteoarthritis pain and chronic low back pain. The agency’s
Drugs
CDER’s Office of Drug Evaluation 1 has denied a PTC Therapeutics appeal of a 2/22 refuse-to-file letter issued by the Division of Neurological Products on an NDA for Translarna (ataluren) for treating nonsense mutation Duchenne muscular dystrophy (nmDMD). At the time, the agency said the submission
Drugs
Purdue Pharma is petitioning FDA to ensure that applications for approval of follow-on products citing its Butrans (buprenorphine) transdermal system as the reference-listed drug are supported by pharmacokinetic data establishing equivalent buprenorphine exposure over the entire seven-day dosing interval. “Absent such data,” the petition says, “there would
Drugs
Gilead says that under the terms of a recent federal court decision, FDA should grant its Stribild (cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarate) five-year new chemical entity (NCE) exclusivity and should extend that exclusivity to all subsequently approved drug products containing any of the new active moieties (elvitegravir and
Drugs
Since 2004, staff in FDA and the European Medicines Agency (EMA) have collaborated through groups, known as clusters, to help solve major challenges facing the agencies. An FDA Voice blog post says that clusters have focused on treatments for children, measures for developing and using biosimilars as cost-effective alternatives