Drugs
FDA has approved the expanded use of Amarin’s Vascepa’s (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk factors. Last month, the agency’s Endocrinologic and Metabolic Diseases Advisory Committee voted 16
Drugs
FDA has released a draft guidance on “Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.” The document’s development was mandated in the 21st Century Cures Act under section 507, Qualification of Drug Development Tools (DDTs). Once finalized, FDA says the document will represent the agency’
Drugs
FDA has released the FDA-483 with seven observations from a 6/10-7/18 inspection at Exela Pharma Sciences, a Lenoir, NC, outsourcing facility. The observations were: * failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * aseptic processing areas are
Drugs
A December CDER Webinar for NDA applicants and holders, patent holders, and regulatory professionals explains updates made to forms FDA 3542a and 3542. The presentation by CDER’s Alicia Chen says the forms were updated to (1) reduce the time needed to complete and process the forms, (2) update certain
Drugs
FDA has released for comment a draft guidance, FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, to address early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original NDAs and
Drugs
FDA has approved an Elite Pharmaceuticals ANDA for a generic version of Shire’s Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate) in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg tablets. The central nervous system stimulant is indicated for treating attention deficit
Drugs
On a near party-line 230-192 vote with only two Republicans joining all Democrats, the House approved 12/12 H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. It now goes to the Senate where it will face significant opposition. President Donald Trump has already said
Drugs
Provention Bio says that as a result of a meeting with FDA staff to discuss the proposed contents of a BLA for its PRV-031 (teplizumab) for prevention or delay of Type 1 diabetes in at-risk individuals, it expects to open a rolling BLA submission mid-2020 and complete
Drugs
FDA has released for comment a draft guidance, FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, to address early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original NDAs and
Drugs
FDA has accepted for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. The submission is based on results from the Phase 3 POLYP 1 and POLYP 2 trials, which showed Xolair
Drugs
The Senate voted 12/10 to approve on a 91-2 vote S. 2740, the Over-the-Counter Drug Safety, Innovation, and Reform Act, which its sponsors say will streamline and modernize FDA’s regulatory system. A statement from Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) says
Drugs
FDA’s Cardiovascular and Renal Drug Advisory Committee has voted 11-2 against recommending approval of Correvio Pharma’s vernakalant for use to rapidly convert recent onset atrial fibrillation to sinus rhythm. Panel members were concerned about safety issues, which included bradycardia, ventricular arrhythmias and deaths recorded in clinical trials.
Drugs
The Council for Responsible Nutrition (CRN), which represents dietary supplement and functional food manufacturers, says it applauds a Supreme Court decision not to hear an Amrin Pharma appeal of a lower court ruling in a fish oil case. In a statement, CRN says the decision “maintains FDA’s proper jurisdiction
Drugs
FDA says 25 unapproved drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, TN have been recalled. In September, a federal court approved a consent decree (see story) against the firms for unlawfully distributing the products. Products that have been recalled include drugs
Drugs
Attorney Kurt Karst (Hyman, Phelps & McNamara) says Congress may be readying a “significant blow” to the Waxman-Hatch Act and the generic drug industry through passage of the Lower Health Care Costs Act of 2019. In a post in his firm’s FDA Law Blog, Karst says the bipartisan,
Drugs
BIO president Jim Greenwood is criticizing the Trump administration and House Speaker Nancy Pelosi for surrendering a “powerful tool for reining in foreign free riding.” In a statement on the apparent agreement on the USMCA trade pact with Mexico and Canada, Greenwood said the renegotiated pact eliminates provisions that prohibit
Drugs
A 4/22-5/20 FDA inspection at Teligent Pharma, Buena, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/26 Warning Letter says the inspection also revealed that the firm failed to submit NDA field alert reports as required by law and
Drugs
A 5/14-5/23 FDA inspection at OHM Pharma, Mineral Wells, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/19 Warning Letter. Specific violations were: * failing to maintain the buildings used in the manufacture, processing, packing, or holding of
Drugs
Preliminary findings from a new Government Accountability Office (GAO) study on FDA’s foreign inspection program acknowledge improvements but point up remaining challenges, such as staffing concerns and reliance on pre-announced inspections. GAO has been evaluating the foreign inspection program routinely for two decades and it remains on the
Drugs
Genus Medical Technologies has won a court decision in Washington, DC federal court to have its contrast agent Vanilla SilQ products regulated as a device as opposed to a drug. Having a product regulated as a device instead of a drug costs significantly less and subjects the company to less
Drugs
FDA says that ongoing concerns about the presence of genotoxic impurities (nitrosamines) in angiotensin II receptor blockers and ranitidine have now spread to some metformin diabetes medicines after other countries reported low levels of the nitrosamine N-Nitrosodimethylamine (NDMA). “Based on the information we have available, the levels of NDMA
Drugs
Republican House lawmakers have introduced the Lower Costs, More Cures Act (H.R. 19) to lower drug costs for Americans without limiting access to cures. The bill “uses bipartisan reforms to lower out-of-pocket spending, protect access to new medicines and cures, strengthen transparency and accountability, and champion competition,