Devices
FDA says it is permitting marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. An agency news release says it reviewed the data for the PIPS through the de novo
Drugs
Reps. David McKinley (R-WV) and Peter Welch (D-VT) have introduced the Fair Access for Safe and Timely (FAST) Generics Act to “thwart manipulation of FDA’s drug safety regulations in order to block the production of generic alternatives to brand name medicines.” The two say the bill would
Drugs
A 9/5-9/14/16 FDA inspection at Mylan Laboratories, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 4/3 Warning Letter. Specific violations included: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any
Devices
FDA has cleared an Alere 510(k) for the Alere Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings. The company says the device will initially be available for use with the BinaxNOW Influenza A & B Card 2, a rapid antigen influenza
FDA Policy/General
FDA and Emulate have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate and qualify the use of Emulate’s Organs-on-Chips technology as a platform for toxicology testing to meet regulatory evaluation criteria for products. The CRADA studies will use Emulate’s Human Emulation System, which
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Indoco Remedies Ltd. Verna, Goa, India (3/27): FDA inspected the firm’s drug manufacturing facility 9/2016 and cited GMP violations related to its finished pharmaceuticals. For example,
Drugs
Three McCullough Robertson attorneys say that “sparse” provisions of the Biologics Price Competition and Innovation Act’s (BPCIA) default protective order addressing issues of prosecution and regulatory bars “leave ample room for the parties to set the scope of the pre-litigation protective agreement and the protective order in effect
Drugs
An 8/31-9/4/16 FDA inspection at Indoco Remedies, Goa, India found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/27 Warning Letter. Specific violations included: * failing to establish and follow adequate written procedures describing the handling of all written
Drugs
A Public Citizen survey finds few major drug company CEOs willing to commit to limiting drug price increases. The group says in a report that only AbbVie, Novo Nordisk, and Valeant were willing to match an Allegan 9/6/16 blog post committing to restricting annual price increases of their
Devices
FDA has cleared a Becton Dickinson 510(k) for a flow cytometer system with a leucocount reagent assay used in residual white blood cell enumeration. The device provides blood banks and clinical laboratories with an “easy-to-use cell analysis solution to help determine and quantify the presence of residual
Drugs
Attorney David Fox (Hogan Lovells) told an AtlanticLIVE biosimilars policy briefing that while progress in the biosimilars market “may seem glacial, by lawyer and FDA standards this market is actually moving at the appropriate pace.” In an online post, Biosimilar Development says that the briefing demonstrated through its presentations that
Devices
FDA has issued Nanobiosym Diagnostics an emergency use authorization for the Gene-RADAR Zika Virus Test. The device is authorized for the qualitative detection of RNA from Zika virus in human serum from individuals meeting Centers for Disease Control and Prevention Zika virus clinical or epidemiological criteria. “Currently, Zika virus
Devices
FDA and other regulatory bodies participating under the International Medical Device Regulators Forum (IMDRF) have released a final guidance document on “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes.” Widespread use of a single adverse event terminology and coding system could improve signal detection by
Devices
FDA has cleared a Verax 510(k) to expand the indications for the Verax Platelet PGD Test to include single units of leukoreduced or non-leukoreduced whole blood derived (WBD) platelets in plasma. The test previously was cleared for testing post storage pools of up to six leukoreduced or non-
Drugs
Isomeric Pharmacy Solutions has recalled all lots of sterile products compounded and packaged that remain within expiry to the hospital/user level due to FDA concerns about a lack of sterility assurance after it recently inspected the firm. Affected products were distributed to patients, providers, hospitals, or clinics nationwide between10/
FDA Policy/General
Philips Healthcare has recalled its Mobile Diagnostic X-Ray System with Digital Panel due to a software design issue. When the operator moves an image to another view option then the electronic marker might be placed at the wrong anatomical position in the resulting image, a recall notice says.
Drugs
FDA in a meeting with Repros Therapeutics has told the company that a partial clinical hold will continue against Proellex (telapristone acetate) and its use in treating uterine fibroids while they consult with liver experts within the agency regarding previously disclosed effects on the liver. “Further, the FDA agreed to
Drugs
Will President Trump’s “America First’ mantra lead to a resurgence in pharmaceutical manufacturing investments in the U.S.? That is the hope of some FDA watchers writing in a Morning Consult op-ed that offers advice on how to spur innovation in domestic manufacturing that could lead to potentially
Devices
Medtronic has recalled all unused units of the StrataMR adjustable valves and shunts due to an increase in product complaints, a rate estimated at 2.75% percent of total units distributed. The recall does not apply to the Strata II or Strata NSC products, according to a recall notice. The
Drugs
Rep. Morgan Griffith (R-VA) has introduced H.R. 2025, the “Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017, a bill to prevent certain drug applications from being considered ineligible for approval on the basis that the proposed labeling includes information describing abuse-deterrent properties that otherwise would be
FDA Policy/General
Antimicrobial Drugs Panel to Discuss Product Development 04/07/2017 Federal Register notice: FDA announces a 4/13 Antimicrobial Drugs Advisory Committee meeting on developing antibacterial drugs that treat a single species of bacteria. Workshop on Kidney Transplant Rejection Drugs 04/05/2017 Federal Register Notice: FDA announces a 4/
Drugs
FDA has issued Merck a complete response letter on supplemental NDAs for Januvia (sitagliptin), Janumet (sitagliptin and metformin HCl) and Janumet XR (sitagliptin and metformin HCl extended-release). In these applications, Merck is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of