Drugs
FDA says it is restricting the use of codeine and tramadol medicines in children due to ongoing concern about serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years. The medicines should also be limited in some older
FDA Policy/General
Federal Register notice: FDA has asked for comments on an information collection: “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” Records required by FDA’s regulations in Part 111 provide the foundation for the planning, control, and improvement processes that
Drugs
AbbVie says that two Phase 3 trials of its veliparib, an investigational oral poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor did not meet their primary endpoints. A company statement says the studies evaluated veliparib in combination with carboplatin and paclitaxel in patients with squamous non-small cell lung cancer and
Devices
Attorneys Cameron Abbott and Giles Whittaker (K&L Gates) say FDA is threatening legal action against Abbott if the company doesn’t address safety and security issues in implanted cardiac devices sold by its recently acquired St. Jude Medical unit. Writing in an online blog post, the two say
Drugs
CDER director of professional affairs and stakeholder engagement John Whyte says the agency has taken steps to promote patient diversity in clinical trials. Writing in a Clinical Leader guest column, Whyte references a 2014 action plan with 27 recommendations in three broad categories: improving the completeness and quality of the
FDA Policy/General
AbbVie says FDA’s issuance of a payor guidance and medical products communications guidance are “an important step forward in improving the communication of information that is related to approved uses and consistent with a drug’s PI but that does not appear in that PI or meet FDA’s
Devices
FDA has cleared a Cardiac Insight 510(k) for its wearable electrocardiogram sensor, Cardea Solo. The device offers physicians immediate access to real-time reporting and analysis of heartbeat-to-heartbeat data. It is intended to be used to assist with diagnosing a variety of arrhythmias, including the most common,
Drugs
Pfizer says it has received grand jury subpoenas from the Justice Department about an antitrust probe into drug makers that market intravenous saline solutions. Reuters reports that subpoenas also were received by ICU Medical, which acquired Pfizer’s global infusion therapy business, and Baxter International. ICU Medical said the probe
Drugs
Three CDER staffers say that drugs and biologics approved by FDA that mention target product profiles (TPPs) are associated with more efficient regulatory review times, perhaps because of increased planning or because the TPP promotes well-organized regulatory dialog. Writing in CellPress, the three say that TPPs are used as
Drugs
FDA has concluded a 4/10-18 inspection at Aurobindo Pharma’s formulations manufacturing facility at Bachupally in Hyderabad, India that resulted in a six-item Form-483. “The observations are all on procedural improvements,” the company said. “None of them are related to data integrity.” A 10/17-10/
FDA Policy/General
The federal government says there are several reasons why the Supreme Court should not hear an appeal filed by Jack and Peter Decoster of their three-month sentence under the Park (responsible corporate officer) doctrine. Attorney Jennifer Thomas (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog
Drugs
Egalet Corp. has submitted a prior approval supplement for Oxaydo (oxycodone HCl, USP) tablets that seeks to market 10 mg and 15 mg dosage strengths for use in treating moderate to severe pain. The submission is based on a pharmacokinetic study demonstrating bioequivalence of Oxaydo to its reference drug, Roxicodone
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-C Ti Cervical Spacer System. The device offers the company’s proprietary titanium surface technology, Osseo-Loc, which is a surface technology that helps create an environment for potential bone growth. It also offers “additional graft windows for increased
Drugs
FDA has released the FDA-483 issued at the end of a 1/18-1/30 inspection at ZS Pharma, a Coppell, TX, active pharmaceutical ingredient (API) manufacturer. Specific violations noted on the form include: * process validation procedures do not ensure the integrity of process validation, and the quality unit
FDA Policy/General
The Senate Health, Education, Labor & Pensions (HELP) Committee has planned a 4/26 vote on Scott Gottlieb to be the next FDA commissioner. Earlier this month, the HELP Committee held a hearing where Gottlieb was grilled about his ties to industry (see earlier story). Gottlieb told members that his
Drugs
CDER has released a list of 103 new and revised draft guidances in 16 categories it plans to issue this calendar year. The categories and number of guidances included are: Advertising (1), Biopharmaceutics (3), Biosimilarity (2), Clinical/Antimicrobial (1), Clinical/Medical (12), Clinical Pharmacology (8), Clinical/Statistical (3), Drug Safety
FDA Policy/General
Federal Register notice: FDA has announced a 5/10 Medical Imaging Drugs Advisory Committee meeting that will discuss a NX Development Corp. NDA for 5-aminolevulinic acid hydrochloride for the proposed indication as an imaging agent to assist in real time detection and visualization of malignant tissue during glioma surgery.
FDA Policy/General
Federal Register notice: FDA has announced a 5/24 Oncologic Drugs Advisory Committee meeting that will review two NDAs. In the morning session, panel members will discuss a Puma Biotechnology NDA for neratinib maleate, indicated as a single agent for the extended adjuvant treatment of adult patients with early-stage
FDA Policy/General
Federal Register notice: FDA has announced a 5/25 Oncologic Drugs Advisory Committee meeting that will discuss a Hospira BLA for a proposed biosimilar product referencing Amgen’s Epogen/Procrit (epoetin alfa), indicated for treating anemia due to certain illnesses. To view the notice, click here.
Devices
FDA has cleared an Edwards Lifesciences 510(k) for its HemoSphere advanced monitoring platform that is intended to provide clinicians with information on a patient’s hemodynamics. The device allows clinicians to “choose the clinical support screens that best suit their needs and monitor the pressures and blood flow of
FDA Policy/General
Federal Register notice: FDA has announced a 5/9-10 workshop to obtain input on issues and challenges associated with federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids for health care providers. To view the notice, click here.
Devices
FDA has cleared an electroCore 510(k) for the gammaCore vagus nerve stimulator for treating acute pain associated with episodic cluster headache in adult patients. The device transmits a mild electrical stimulation to the vagus nerve through the skin, resulting in reduced pain. The clearance is based on subgroup analyses