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FDA’s Breakthrough Therapy Designation and Expedited Review Programs: Part II

RegulatorFDA2016-04-26 12:55 Read   161

PART II – Review and comparison of CDER’s expedited programs

FDA’s Breakthrough Therapy Designation and Expedited Review Programs: Part I

RegulatorFDA2016-04-26 12:49 Read   134

For more than two decades, CDER has employed expedited pathways aimed at speeding the drug development and review processes so that therapies that show early promise can reach patients faster.

States' efforts to fight skyrocketing costs pose 'modest risk to pharma': Report

Regulatorfiercepharma2016-04-25 09:42 Read   79

States across the country have been battling it out with Big Pharma over drug pricing, with some introducing bills that take aim at skyrocketing costs.

FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior

RegulatorFDA2016-04-25 08:47 Read   114

The U.S. Food and Drug Administration today announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.

FDA bats back Sarepta’s counterattack as a final showdown looms over Duchenne drug

Regulatorfiercebiotech2016-04-22 09:48 Read   83

Sarepta’s regulatory team came out swinging after the FDA issued a harsh review of its Duchenne muscular dystrophy drug last January.

Catalent plant gets 14 observations from FDA

Regulatorfiercepharma2016-04-21 14:34 Read   101

Miami-based Opko was caught off guard last month when the FDA cited concerns over a Catalent ($CTLT) plant in Florida that is producing its drug candidate as the reason the agency was putting off its decision on whether to approve it.

China FDA slams 3 drugmakers on manufacturing lapses

Regulatorfiercepharma2016-04-20 16:57 Read   94

China FDA has ordered 3 drugmakers to recall certain products off the shelf in the latest effort to enforce good manufacturing practices (GMP) on the firms suspected of sending medicines to the market that failed origin, labelling, data and quality assessments.

FDA pulls approvals on AbbVie's ex-blockbuster heart meds

Regulatorfiercepharma2016-04-20 14:23 Read   116

Years after two AbbVie cholesterol-fighting combos were approved, the FDA has decided they shouldn’t be on the market.

FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens

RegulatorFDA2016-04-20 09:58 Read   108

The U.S. Food and Drug Administration announced today it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use.

Chiasma Shares Crater as FDA Rejects Hormone Drug, Asks For More Data

Regulatorxconomy2016-04-19 16:52 Read   106

Chiasma was on the doorstep of possible of approval of its first drug, a potential treatment for a rare hormonal disorder called acromegaly.

Product-Specific Recommendations for Generic Drug Development

Regulatorfirstword2016-04-18 13:57 Read   95

To successfully develop and manufacture a generic drug product, an applicant should consider that their  product is expected to be:  pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use,  bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient;  and, consequently,  therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug. 

Long-term vaccine management system planned

Regulatorenglish.gov.cn2016-04-18 13:39 Read   107

Two government departments started studying the establishment of a long-term vaccine circulation and inoculation management system, according to their spokesmen on April 13.