Drugs
FDA and Commonwealth Informatics have signed a new contract to support the use of advanced drug safety review tools at CDER and CBER. Under the new agreement, Commonwealth will support the expanded use of its “analytic suite of tools to help FDA manage their drug and product safety proactively and
Drugs
An FDA 12/15 final rule lists six substances the agency has evaluated and is proposing to include on a list of bulk drug substances that can be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. The rule also lists four substances that the
Drugs
The HHS Inspector General finalized 12/7 a rule amending the safe harbor regulations under the federal healthcare program antikickback law and established exceptions to the civil monetary penalty prohibiting remuneration to Medicare and Medicaid beneficiaries. Attorneys Alan Kirschenbaum and David Gibbons (Hyman, Phelps & McNamara) write in their firm’
Drugs
The winner of a $40,000 cash prize in the 2016 FDA Naloxone App Competition was OD Help, developed by Team Pwrdby, a small startup based in Venice, CA. FDA associate commissioner for public health strategy and analysis Peter Lurie says the prize competition wanted to find innovative solutions to
Drugs
CDER director Janet Woodcock does not appear too concerned with an Administration change next month, saying that for now it is business as usual and the work of the Center goes on. Speaking to CNBC reporter Meg Tirrell, Woodcock noted that she has been at FDA for over three decades
Drugs
The Washington Legal Foundation (WLF) is asking the California Supreme Court to reject a lower state court’s finding that Novartis could be held liable for injuries suffered by twins in utero after their mother took a generic version of an asthma medication (terbutaline) made by another company. A WLF
Drugs
The attorneys general from 20 states have filed a federal lawsuit that alleges six pharmaceutical companies violated antitrust laws by conspiring to fix prices and allocate markets for various generic drugs. The lawsuit was filed against against Heritage Pharmaceuticals, Inc., Aurobindo Pharma USA, Inc., Citron Pharma, LLC, Mayne Pharma (USA)
Drugs
Ten Hogan Lovells attorneys says the 21st Century Cures Act signed by President Obama unleashes “an expansive suite of measures designed to deliver new cures and treatments to patients.” They highlight key provisions in FDA’s regulation of drugs and biologics: * require HHS/FDA guidance on novel clinical trial designs;
Drugs
FDA says that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than three years or in pregnant women during their third trimester may affect development of children’s brains. An agency drug safety communication says recent human studies suggest that a
Drugs
Attorney James Beck (Reed Smith) says that his review of court cases and other sources indicates that preemption should apply to almost all warnings related to over-the-counter products for which there is at least a tentative monograph. “The same combination of a ‘sameness’ requirement and absence of any
Drugs
Osmotica Pharmaceutical is asking FDA to require that any ANDA seeking approval of venlafaxine HCl extended-release tablets 225 mg and referencing the company’s NDA-approved product demonstrate in vivo bioequivalence using the 225 mg strength. A 12/9 citizen petition says the agency generally recommends that in vivo
Drugs
FDA has extended until 4/10/2017 the comment period on its initiative to review “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” FDA says the comments will inform policy development in this area — something the agency has been uncomfortable with for a long time in the
Drugs
CDER is issuing more complete response letters this year, and it is significantly reducing the number of new molecular entity (NME) approvals, retiring Office of New Drugs director John Jenkins says in his annual review of the Center’s approval performance. Factoring in fewer NME submissions and five applications that
Drugs
FDA and HHS’ Office for Human Research Protections have released a guidance on “Use of Electronic Informed Consent (eIC) — Questions and Answers” that provides recommendations on procedures that may be followed when using an electronic informed consent. The document addresses topics such as how to present information in the eIC
Drugs
FDA has approved an Anacor Pharmaceuticals NDA for Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. Approval was based on data from two placebo-controlled trials with a total of 1,522 participants ranging in age from two years
Drugs
FDA has selected Department of Justice Office of International Affairs attorney Donald D. Ashley as CDER’s next Office of Compliance director, effective 1/9/2017. Ashley replaces Cynthia Schnedar, who recused herself a year ago from working on substantive compliance actions because her husband, Mark Polston, had been named
Drugs
FDA has approved a Vericel PMA for Maci (autologous cultured chondrocytes on porcine collagen membrane) for repairing symptomatic, full-thickness knee cartilage defects in adult patients. An agency release says Maci is the first approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy
Drugs
President Obama 12/13 signed into law the 21st Century Cures Act, which will provide a $500 million funding boost for FDA over the next 10 years. The new law also builds on the agency’s “ongoing efforts to advance medical product innovation and ensure that patients get access to
Drugs
FDA says it has speeded up its release of drug safety information on its Web site that houses labeling changes made post approval. “Our improved Drug Safety Labeling Changes Program enables FDA to post the latest safety information about a medicine almost at the same time we approve a change,
Drugs
The Association of American Medical Colleges (AAMC) says that an FDA draft guidance on procedures for evaluating appearance issues and granting authorization for participation in FDA advisory committees would benefit from additional clarification. The association also says it is pleased that the agency drafted the document, which seeks to explain
Drugs
FDA says that as a result of an updated review, it has determined that using the Type 2 diabetes medicine pioglitazone (Takeda’s Actos, Actoplus Met, Actoplus Met XR, and generic combination drugs Duetact and Oseni) may be linked to an increased risk of bladder cancer. An agency drug safety
Drugs
Ophthotech says two Phase 3 studies evaluating its wet age-related macular degeneration (AMD) drug Fovista (pegpleranib) failed to meet the pre-specified primary endpoint of mean change in visual acuity at 12 months. The studies are evaluating Fovista in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy. The two