Drugs
President Donald Trump 1/31 offered assembled pharmaceutical CEOs a deal: We shorten your 15-year new drug development time through a huge reduction in unnecessary FDA regulations on that process, and you repay us with a huge reduction in the prices you charge the American people. To sweeten the
FDA Policy/General
Public Citizen president Robert Weissman says that President Donald Trump’s 1/30 Executive Order requiring agencies to propose two regulations for repeal for every one that they want to issue is “as radical and unworkable as the other ones Trump has signed.” In a statement, Weissman says that the
Drugs
Merck says that the scope of a draft FDA guidance on the format and content of physiologically based pharmacokinetic (PBPK) analyses should be expanded since such modeling supports sNDAs and sBLAs as well as INDs, NDAs, BLAs, and ANDAs. Also, the letter says, FDA acknowledges that the depth and breadth
FDA Policy/General
Fearing that a hiring freeze could impact the implementation of the 21st Century Cures Act, Democratic senators on the Health, Education, Labor and Pensions Committee are asking FDA for answers on how the federal hiring freeze (see earlier story) will affect the agency. “A hiring freeze at the FDA would
Drugs
FDA has denied an Acorda Therapeutics petition that asked the agency to “carefully consider the sufficiency of the applicant’s identification and qualification of potentially genotoxic impurities in reviewing an ANDA referencing its Ampyra (dalfampridine) extended release tablets.” The company petition says that certain potentially genotoxic impurities that may be
Drugs
FDA has approved two Teva Pharmaceutical Industries NDAs for AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder), both indicated for use in asthma patients. AirDuo is a fixed dose combination product containing the same active ingredients as GlaxoSmithKline’s Advair, indicated for treating
FDA Policy/General
FDA’s Office of Regulatory Affairs (ORA) plans to implement its long-awaited Program Alignment Group initiative by 5/15. Under the plan, the field force will shift to a commodity-based, vertically integrated inspection program, with specialized inspection cadres for FDA-regulated products and inspection operations. “ORA will maintain
Devices
FDA has approved a W. L. Gore PMA for the Gore Viabahn VBX Balloon Expandable Endoprosthesis for treating de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. The device’s approval was based on a study that “demonstrated notable immediate and nine-month safety
Drugs
FDA has told Regulus Therapeutics that a 6/2016 clinical hold remains in effect and it requested more information on the development program for RG-101, an investigational therapy for treating chronic hepatitis C virus (HCV). The hold was originally placed after the company reported a second serious adverse event
FDA Policy/General
President Donald Trump 1/30 signed an executive order requiring FDA and other government agencies to eliminate two existing regulations for every new rule introduced. “This will be the biggest such act that our country has ever seen,” Trump said in a signing ceremony. “There will be regulation, there will
Devices
Bard Peripheral Vascular has recalled its Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from a patient’s leg. The company also reports that the sheath may kink, and that its tip may become damaged during the procedure,
FDA Policy/General
FDA Confirms Effective Date of Color Additive Addition Federal Register Notice: FDA has confirmed a 12/2/2016 effective date for a final rule that appeared in the 11/1/2016 Federal Register that amended the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato
Drugs
While a Twitter blockade ordered by the Trump Administration prevents FDA employees from communicating with the public and industry, agency employees have launched a “parody” Twitter account called @AltFDA to help keep agency information flowing. The rogue Twitter account follows in the pattern of other government agency employees who have
Drugs
FDA says its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not
FDA Policy/General
FDA failed to address all issues outlined in a House Energy and Commerce Committee request about performance measures involving the Office of Criminal Investigations (OCI). Last September, committee leaders wrote the agency (see story) asking for information in the wake of information from independent watchdogs that identified weaknesses in the
Drugs
FDA has granted AstraZeneca six months pediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol, which is currently approved in the U.S. to treat asthma in patients 12 years and older and for the maintenance treatment of chronic obstructive pulmonary disease in adults. The agency’s decision was based on
Devices
FDA has cleared a Zeltiq Aesthetics 510(k) for the CoolSculpting device and its use for removing fat on upper arms. The upper arm area will be treated using the company’s CoolAdvantage Petite applicator, which comes with two interchangeable contours designed to treat the area in 35 minutes, the
Devices
BioMerieux has expanded an 8/2016 Class 1 recall of its NucliSENS easyMAG Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance. MagSil is used to extract and purify genetic material from patient samples. “Kits with the affected lots of the Magnetic silica have exhibited a decrease of
FDA Policy/General
Former HHS secretary Sylvia Mathews Burwell (Obama Administration) has been named president of American University in Washington, DC. She succeeds Neil Kerwin as president and will assume her duties 6/1. Burwell is the first woman to hold the highest leadership position at AU. Previously, Burwell held leadership roles in
Drugs
A 10/17-10/25/16 FDA inspection at Aurobindo Pharma, Borpatla Village, India, found that equipment cleaning procedures were not adequately validated. A just-released FDA-483 shows the deviation from current good manufacturing practice regulations for active pharmaceutical ingredients.
Drugs
FDA has cleared a DePuy Synthes 510(k) for the Viper and Expedium Fenestrated Screw Systems. When used with the company’s Confidence High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors, the company says. The
FDA Policy/General
Two ranking Democrats on the House Energy and Commerce Committee and the Oversight and Government Reform Committee are pushing back on White House gag orders reportedly dictated to HHS and other departments. Reps. Frank Pallone, Jr. (D-NJ) and Elijah E. Cummings (D-MD) sent a letter 1/26 to