Devices
A 10/24-10/28/16 FDA inspection at DRG Instruments, Marburg, Germany, found Quality System Regulation violations in the firm’s manufacturing of 17-alpha-OH Progesterone ELISA, Salivary Cortisol ELISA, Estradiol ELISA, Salivary Testosterone ELISA, and Testosterone ELISA. Specific violations noted in a 9/19 Warning Letter were:
FDA Policy/General
Federal Register notice: FDA has classified as Class 2 devices that detect and measure non-microbial analytes in human clinical specimens to aid in assessing patients with suspected sepsis. The action was taken in response to a 3/2015 Thermo Fisher Scientific de novo classification request for the BRAHMS PCT
FDA Policy/General
Federal Register notice: FDA has withdrawn the marketing approval of 54 ANDAs requested by Watson Laboratories and Barr Laboratories. The companies notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. DRG Instruments GmbH Marburg, Germany (9/19): FDA inspected the firm 10/2016 and cited significant GMP deviations with the 17-alpha-OH Progesterone ELISA, Salivary Cortisol ELISA, Estradiol
Devices
FDA commissioner Scott Gottlieb says the agency’s Medical Device Innovation Access Plan is intended to enable patients and providers to have efficient access to new and innovative medical products that meet the agency’s standard for safety and effectiveness. His statement says FDA is taking new steps to promote
Devices
FDA has cleared an Ortek Therapeutics 510(k) for the Ortek ECD, a lightweight tabletop device designed as an aid for dental professionals to diagnose and monitor dental cavities in the biting surfaces of molars and premolars. In clinical trials, the device detected the earliest forms of mineral loss in
FDA Policy/General
Federal Register notice: FDA has announced support for the most current B3-format annual version of the World Health Organization Drug Global (formerly named WHO Drug Dictionary), and an update to the FDA Data Standards Catalog for study data provided in drug/biologic submissions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has denied a requested for a hearing and has issued an order debarring Trang Doan Nguyen for five years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Nguyen
Devices
FDA has issued a Warning Letter to Magellan Diagnostics for modifying versions of two of its blood lead testing systems without the agency’s required clearance or approval and for failing to submit medical device reports after becoming aware of customer complaints involving discrepancies in blood lead test results. The
Drugs
SCA Pharmaceuticals is recalling all lots of several injectable products because there is a potential for them to contain microbial contamination. To date, the company says it has not received any customer complaints or reports of adverse events related to the issue. Affected products include succinylcholine chloride 20 mg/mL
FDA Policy/General
FDA has approved an AstraZeneca NDA for Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation designed for an improved once-weekly, single-dose autoinjector device for adults with Type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines, in addition to diet and exercise,
FDA Policy/General
Federal Register notice: FDA has determined that AstraZeneca’s Elavil (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs if all other legal
Biologics
Biosimilar approvals should help cut healthcare spending by $54 billion over the next decade, according to a new analysis from the RAND Corporation. The cost savings projection is almost 20% greater than a similar analysis done by the researchers three years ago, “representing both improved analysis methods and rapid growth
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Baxter’s Obizur is 4,216 days, and of this time 3,883 days occurred during the testing phase and 333 days occurred during the approval phase. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets. When finalized, the document will provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs for such products. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Inspire’s Upper Airway Stimulation System is 2,002 days, and of this time, 1,653 days occurred during the testing phase and 349 days occurred during the approval phase. The product is indicated
Drugs
FDA has approved Janssen Biotech’s Simponi Aria (golimumab) for treating adults with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). The therapy was first approved in 2013 for treating moderate to severe active rheumatoid arthritis. The two new indications were approved based on data that “demonstrated the significant
Drugs
FDA has approved a GlaxoSmithKline BLA for its Shingrix (zoster vaccine recombinant, adjuvanted) for preventing shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses. Approval was based on data from a Phase 3 clinical trial program
Biologics
Octapharma USA has decided to withdrawal two lots of Octagam 10% [immune globulin intravenous (human)] liquid preparation] that is labeled with lot numbers K724B8541 and K725A8541. “Although there have been no reports of serious injury at this time,” an FDA online notice says, “Octapharma has determined through consultation with the
Drugs
FDA Extends Deadline for Lab Test Identifiers in Applications Federal Register notice: FDA announces an extension of the deadline to provide Logical Observation Identifiers Names and Codes for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to CDER and CBER. 10/20/2017 Class 2
Drugs
As part of its initiative to help generic manufacturers get more applications approved, FDA has published 51 product-specific guidances (32 new and 19 revised) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs. FDA
Devices
Post-hurricane troubles in Puerto Rico are not unique to pharmaceutical manufacturers — FDA says it is paying equal attention to medical device makers on the island who are struggling to return production and distribution to pre-storm levels. In a 10/20 post-hurricane update, FDA commissioner Scott Gottlieb says