Drugs
FDA is ramping up its efforts to improve the process for developing generic copies of complex drugs, according to commissioner Scott Gottlieb. These are products that involve a complex formulation or a complex active ingredient, and include inhaled drugs and eye drops that can’t be easily measured in the
Devices
An FDA safety alert warns that dietary supplements containing biotin (vitamin B7) can cause clinically significant incorrect lab test results. The agency says it is seeing an increase in reported adverse events, including one death, related to biotin interference with lab tests. “Biotin in patient samples can cause falsely high
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dae Young Foods Co. Seoul, Korea (11/20): FDA inspected the firm in March and documented significant GMP violations for finished pharmaceuticals. For example, the firm failed to visually
Drugs
A Tufts Center for the Study of Drug Development white paper says that innovative biologics manufacturing is reducing production costs while fundamentally changing how life-saving drugs are produced. The white paper is based on a 10/2015 roundtable discussion that included senior managers from biologics development companies and officials
Drugs
Regeneron Pharmaceuticals says two Phase 2 studies looking at adding investigational drug nesvacumab to the company’s already-approved Eylea (aflibercept) injection did not provide “sufficient differentiation” to move into Phase 3 development. The RUBY study examined patients with diabetic macular edema (DME) and the ONYX study evaluated patients with
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Export of FDA-Regulated Products: Export Certificates OMB Control Number 0910-0498.” The collection is authorized by the FDA Export, Reform, and Enhancement Act of 1996 that was designed to ease restrictions on exporting unapproved pharmaceuticals, biologics,
Devices
Sen. Chuck Schumer (D-NY) has called on the Federal Trade Commission to examine direct-to-consumer home DNA kits to ensure genetic information is not sold or shared with third parties without consumers’ informed consent. Schumer 11/26 cited the increasingly popular home genetic kits (Ancestry, 23andMe and MyHeritage)
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” The document discusses the circumstances where packages and homogenous cases of product not labeled with a product identifier shall be exempted and grandfathered from certain drug
FDA Policy/General
Federal Register notice: FDA has announced a 1/11/2018 public workshop entitled “Safety Assessment for IND Safety Reporting.” Convened under a cooperative agreement between the agency and the Duke-Robert J. Margolis Center for Health Policy, the workshop is intended to discuss a variety of topics related to an
Drugs
Sun Pharmaceutical Industries has recalled (Class 2) two lots of Riomet (metformin hydrochloride oral solution), 500 mg/5mL, due to Scopulariopsis brevicaulis contamination, which was discovered during sample preparation for an antimicrobial preservative effectiveness test that was being performed as part of required 12 month stability study. Riomet is indicated
Devices
FDA has released a guidance on “Pediatric Information for X-ray Imaging Device Premarket Notifications” that outlines the agency’s current thinking on information to include in 510(k)s for such devices that are indicated for pediatric populations or general use x-ray imaging devices when considerable pediatric use
Drugs
A former compliance director at Indiana compounding pharmacy Pharmakon Pharmaceuticals has pleaded guilty to introducing adulterated drugs into interstate commerce and conspiracy to defraud the U.S. by obstructing FDA functions. Caprice Bearden (Carmel, IN) pleaded guilty in southern Indiana federal court to one count of conspiracy, three misdemeanor counts
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Electronic Records; Electronic Signatures OMB Control Number 0910-0303.” The agency’s regulations establish criteria for accepting electronic records, electronic signatures, and handwritten signatures executed to electronic records as being equivalent to paper records. Under the regulations,
Drugs
BioMarin Pharmaceutical has agreed to sell for $125 million its Rare Pediatric Disease Priority Review Voucher (PRV) it was awarded by FDA in April when it received approval for Brineura, a new biological product for patients with late infantile neuronal ceroid lipofuscinosis type 2, a form of Batten disease. The
FDA Policy/General
Guide on Generic Abuse-deterrent Opioids Federal Register notice: FDA makes available a guidance entitled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” 11/22/2017 Panel to Review Clarus Therapeutics Testosterone Replacement Federal Register notice: FDA announces a 1/9/2018 Bone, Reproductive
Drugs
DEVICES FDA has approved a Medtronic PMA for its Azure pacemakers with BlueSync technology. The devices are available in both single chamber and dual chamber models, and offer improved longevity, estimated at 13.7 years, according to the company. The new pacemakers also allow patients to have magnetic resonance imaging
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.”’ The document recommends studies, including comparative in vitro and pharmacokinetic studies, that a potential ANDA applicant should conduct and submit to FDA to demonstrate that a
FDA Policy/General
Federal Register notice: FDA has announced a 1/9/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting in Hyattsville, MD. Panel members will discuss a Clarus Therapeutics NDA for testosterone undecanoate capsules, indicated for testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone:
FDA Policy/General
Federal Register notice: FDA has announced a 2/7-8/2018 public workshop entitled “Tenth Annual Sentinel Initiative Public Workshop” to discuss a variety of topics on active medical product surveillance. It is also intended to provide an understanding of how to use the Sentinel System’s tools to address
FDA Policy/General
Stakeholders are responding with agreement and objection to an FDA request for information and comment on its proposal to change requirements for the content of the so-called major statement that outlines prescription drug risks in direct-to-consumer (DTC) broadcast ads. The National Association of Broadcasters says the agency
Drugs
Harvard Medical School researchers say that in some situations, database studies may support supplemental applications for effectiveness for already approved drugs. Writing in JAMA Internal Medicine, the researchers describe their use of healthcare databases to replicate the study of Boehringer Ingelheim’s antihypertensive Micardis (telmisartan) for a supplemental indication to
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that an Amherst Pharmaceuticals Web page for Zolpimist (zolpidem tartrate) oral spray and Magna Pharmaceuticals’ convention exhibit panels for Zolpimist make false or misleading claims and/or representations about the risks associated with the drug’s efficacy. An 11/14 Warning