Drugs
FDA has published a guidance, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, to help government public health and emergency response stakeholders determine if stockpiled doxycycline tablets and capsules have retained their purity and potency beyond the manufacturer’s labeled expiration date so the replacement of stockpiled
Drugs
FDA has published a draft guidance, Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes, to give the agency’s recommendations for adjusting for covariates in randomized clinical trials with continuous endpoints that are appropriate for analysis with normal-theory methods, such as the two-
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.” The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and
FDA Policy/General
Federal Register notice: FDA has announced a 5/30-31 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. On 5/30, panel members will discuss and make recommendations on a reclassification proposal for surgical stapler devices for internal use from Class 1 (general controls) to
FDA Policy/General
Federal Register notice: FDA has made available an update to the immediately in effect guidance entitled “Compliance Policy for Combination Product Postmarketing Safety Reporting.” The document describes FDA’s compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety
Devices
FDA has granted Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-eluting Balloon (SEB) for treating coronary in-stent restenosis (ISR). “The unique design of Virtue SEB provides a reliable way to apply the proven anti-proliferative, anti-restenotic benefits of sirolimus during balloon angioplasty without the potential
Drugs
FDA says that Empire Distributors is selling an unapproved new drug, Rhino Black 5K Plus, from its Web site and Amazon.com storefront. A 4/10 Warning Letter says laboratory analysis confirmed that the product contains undeclared active pharmaceutical ingredients sildenafil and tadalafil, used in the branded drugs Viagra and
FDA Policy/General
In a case that could have implications for FDA and many other federal agencies, the Supreme Court is being asked by the Food Marketing Institute to broaden one of the exemptions under the Freedom of Information Act (FOIA) so the government can refuse to disclose SNAP (formerly Food Stamp) program
Devices
AdvaMed says that while it appreciates FDA publication of a draft guidance on non-binding feedback after certain FDA medical device establishment inspections, the draft does not satisfactorily deliver the result that is sought — using agency feedback on remediation of inspectional observations to assure that the remediation effectively and efficiently
Drugs
CDER has issued a Manual of Policies and Procedures for its new Biopharmaceutics Council, a multi-disciplinary and cross-organizational panel providing senior management support on development and application of policies, practices, and recommendations related to biopharmaceutics in drug review processes, as well as to other CDER programs, as appropriate.
Devices
FDA has approved B. Braun Medical’s heparin sodium injection, USP. The company describes it as the first heparin 5,000 USP Unit/0.5 mL prefilled syringe with attached safety needle for subcutaneous and intravenous use in the U.S. It is preservative-free, not made with natural rubber
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify surgical staplers for internal use (currently regulated under the classification for “manual surgical instrument for general use” and assigned the product code GAG) from Class 1 (general controls) into Class 2 (special controls) and subject to premarket review. The reclassification is related
FDA Policy/General
FDA has issued a draft guidance, Initiation of Voluntary Recalls Under 21 CFR part 7, Subpart C, on the timely initiation of voluntary recalls of FDA-regulated products. The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures;
Drugs
In a report to Congress, FDA says it “remains concerned about the resources required to respond to 505(q) petitions within the statutory deadline at the expense of completing other work of the agency.” The report says Section 505(q) of the Federal Food, Drug, and Cosmetic Act applies to
Devices
FDA has cleared a Konica Minolta Healthcare Americas 510(k) for its Dynamic Digital Radiography (DDR). The device produces medical images that depict movement and can be annotated, including diagrams, to help radiologists provide a more detailed clinical finding, the company says. “DDR, an enhanced X-ray technology, enables clinicians
Devices
FDA has issued a proposed order reclassifying certain surgical staplers and a draft guidance to help manufacturers ensure their surgical stapler and staples labeling provides adequate directions for use. CDRH director Jeffrey Shuren says the agency alerted the public and healthcare professionals 3/2019 about concerns with surgical staplers for
Drugs
The Association for Accessible Medicines says it supports the underlying goals of an FDA draft guidance on competitive generic therapies (CGT), and believes the agency could clarify how CGT designations and exclusivity will be determined and communicated to applicants. The association’s comment letter says (1) FDA should provide greater
Devices
A 4/9-4/25/18 FDA inspection of Abaxis, Inc., Union City, CA, found violations in the firm’s manufacturing and distribution of Class 1 and Class 2 in-vitro diagnostic reagents including the Piccolo Xpress chemistry analyzer and associated rotor panels/assays. A 4/12 Warning Letter says
FDA Policy/General
Researchers with CDER’s Office of Prescription Drug Promotion and RTI International say new research into effects of direct-to-consumer drug advertising and promotion is needed given the changing environment in which such ads are used. Writing in Health Communication, the researchers say their review synthesized the research literature
Devices
FDA has cleared an AliveCor 510(k) for its KardiaMobile consumer electrocardiogram (ECG) technology for expanded use to detect and show ECG results for bradycardia and tachycardia. Previously, the device was cleared to detect atrial fibrillation (AFib) and normal sinus rhythm. AliveCor says the new instant analyses indicate arrhythmias that
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Abaxis, Union City, CA (4/12): FDA inspected the firm 4/9-25 and cited changes the company made to its Piccolo
FDA Policy/General
Federal Register notice: FDA has announced a 5/16 public meeting entitled “Characterizing FDA’s Approach to Benefit-Risk Assessment Throughout the Medical Product Life Cycle.” The meeting is intended to gather stakeholder input on applying FDA’s Benefit-Risk Framework throughout the human drug lifecycle and best approaches to